Arch Linux Iso File Jobs in Usa

Immediate need for a talented R&D Project Manager. This is a 12+ months contract opportunity with long-term potential and is located in San Diego, CA(Hybrid). Please review the job description below and contact me ASAP if you are interested.

Job ID:26-08555

Pay Range: $60 - $90/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Lead and manage multiple R&D programs and/or large-scale product development projects, from feasibility through commercialization, including Class II and/or Class III medical devices (with emphasis on electrically active/medical electrical equipment where applicable).
• Develop and maintain integrated program plans, timelines (Gantt charts), budgets, resource plans, and risk registers; proactively identify and mitigate risks across technical, regulatory, clinical, commercial, and electrical safety dimensions.
• Define project scope, objectives, deliverables, and success criteria; create and maintain project charters, work breakdown structures (WBS), and detailed schedules.
• Lead cross-functional core teams (R&D/Engineering, Quality, Regulatory Affairs, Clinical, Manufacturing, Marketing, and Operations) to execute program objectives; facilitate effective decision-making and resolve conflicts.
• Drive adherence to Design Control processes (21 CFR 820.30), risk management (ISO 14971), usability engineering (IEC 62366), basic safety and essential performance requirements for medical electrical equipment (IEC 60601-1 series), and other applicable standards throughout the product lifecycle.
• Provide regular status updates, executive-level reporting, and dashboards to senior leadership and stakeholders; communicate program progress, issues, decisions, and changes clearly and proactively.
• Support regulatory strategy development and submissions (e.g., 510(k), PMA, technical files for CE marking), including coordination of electrical safety testing, EMC compliance (IEC 60601-1-2), and collateral/particular standards as needed.
• Foster a collaborative, innovative, and compliant culture within program teams.
• Oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and cross functional teams management.
• Lead cross-functional teams through identification of risks & mitigations, problem resolution and root cause analysis, corrective and preventive action.
• Develop and maintain integrated project plan with risk-based timeline, critical path milestones, resource allocation, roadmap with clear milestones for gap analysis, risk management, remediation, testing, certification and budget tracking to support certification goals
• Monitor the effectiveness and performance of the launch and project team and facilitate the development of contingency plans, recommending corrective actions as required.
• Ensure compliance with quality management systems and regulatory requirements, where applicable.
• Lead the team to prepare for and execute Phase Gate. Represent the team with Client leaders, ensuring such decisions are informed by a balanced and clearly articulated representation of the relevant data.
• Leverage technical acumen to partner with engineering teams, monitor development progress, and ensure alignment between technical deliverables and program timelines
• Drive design control discipline throughout product development, ensuring compliance
• Conduct or oversee gap assessments against general, collateral, and particular standards for medical electrical equipment safety and essential performance.
• Manage integrated risk management (per ISO 14971), including essential performance definition, hazard analysis, risk controls, and verification.
• Coordinate and manager the execution of test plans for electrical safety, EMC, mechanical, environmental, and essential performance requirements; coordinate pre-compliance and formal third-party testing.
• Oversee compliance documentation: technical files, risk management files, test reports, essential performance rationale, and certification justification.
• Integrate compliance activities with the quality management system (ISO 13485) and other regulatory requirements (FDA, EU MDR, etc.).
• Serve as primary liaison with notified bodies, test labs, and regulatory consultants to support certification and post-compliance needs.
• Drive a safety-focused culture while ensuring the team meets the September 2027 compliance target

Key Requirements and Technology Experience:

• Key Skills;Bachelor’s degree in Engineering (Biomedical, Electrical, Mechanical, or related),Life Sciences, or equivalent.
• 3-5 years of project management in medical devices, with ≥5 years leading compliance programs for medical electrical equipment.
• Proven track record of successfully delivering medical device programs from concept to market launch (including regulatory clearance/approval).
• Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 14971 risk management, IEC 62304 (software), and global regulatory pathways (510(k), De Novo, PMA, MDR).
• Proficiency with project management tools (e.g., MS Project, Jira, Smartsheet, or similar) and standard office software.
• Project Management Professional (PMP) certification not required but is preferred
• Scrum Master and SAFE Agile certification is preferred.
• Experience in medical device industries required, including experience in FDA or other regulated environments.
• Knowledge of the medical device industries beneficial integrating science and technology into business processes.
• Technical background in electrical, mechanical, or biomedical engineering
• Expert in the development and deployment of program management tools and techniques including methods for tracking progress, risk management and delivery of major milestones.
• Understanding of engineering development lifecycles and the ability to translate technical inputs into program-level actions and timelines
• Excellent influencing skills with the ability to achieve challenging goals through others without direct authority across different functions, external partners, geographies, and cultures.
• Drive for accountability within self and others.
• Proven project management experience with delivering medium-to large-scale projects in managed service model from concept through delivery and operations
• Relentless advocacy for the customer with a focus on meeting or exceeding customer requirements.
• Driving the team to make trade-offs that optimize customer and business value while maintaining program velocity and outcomes that sustain the highest standards of quality.
• Direct experience with major test labs and certification bodies for medical electrical equipment standards.
• Experience with programmable electrical medical systems (PEMS) or software-inclusive devices (IEC 62304 knowledge a plus)
• Proven success taking Class II (or higher) active medical electrical devices from gap assessment through third-party certification.
• Strong knowledge of ISO 14971, ISO 13485, general/collateral/particular standards for medical electrical safety and essential performance, and EMC requirements.
• Familiarity with FDA QSR (21 CFR Part 820), EU MDR/IVDR, or other global regulations.

Our client is a leading Pharmaceutical Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here.

• Competitive base rate - $22.00-$32.20/ hour depending on experience.15% shift differential.
• Medical/Prescription Drug/Dental/Vision Benefits on Day 1 of employment
• 401(k) Retirement Savings Plan
  • 4.5% company match if you contribute at least 5%
• Quarterly Bonus potential
• Paid Time Off (PTO)
• 8 company paid holidays per year
• Employer paid Life Insurance, AD & D plus optional coverage for yourself, spouse and child(ren)
• Employee Assistance Program
• MN Paid Leave/and/or Short-Term Disability provided by ARCH
• $1,000 Sign on Bonus

• Inspects products during the machining operation to determine if parts meet specifications, complying with established standards and methods for inspection, testing, evaluation and calibration
• Follow all job work order instructions
• Must be able to run more than one machine where cycle time permits
• Complete all required shop floor documentation for the job including both part-dimensional and visual inspection
• Maintain equipment by completing preventive maintenance requirements; following manufacturer's instructions; troubleshooting malfunctions; reports to management/maintenance the need for machine repairs
• Understands and comply with company policy safety guidelines, quality systems requirements and housekeeping standards

• High school diploma or GED equivalent
• Due to contractual requirements, this position is subject to the International Traffic in Arms Regulations (ITAR) which requires U.S. person status. ITAR defines U.S. person as an U.S. Citizen, U.S. Permanent Resident (i.e. 'Green Card Holder'), Political Asylee, or Refugee.

• Machine Tool Technology degree (completed or pursuing)
• A minimum of 1 years' experience operating a CNC Lathe machine
• Strong mechanical aptitude
• Ability to read and understand blueprints
• Strong attention to detail
• Effective verbal and written communication skills

Position Summary:

The Scientific Computing and Data group at the Icahn School of Medicine at Mount Sinai partners with scientists to accelerate scientific discovery. To achieve these aims, we support a cutting-edge high-performance computing and data ecosystem along with MD/PhD-level support for researchers. The group is composed of a high-performance computing team, a clinical data warehouse team and a data services team.

The Lead HPC Architect, Cybersecurity, High Performance Computational and Data Ecosystem, is responsible for designing, implementing, and managing the cybersecurity infrastructure and technical operations of Scientific Computing’s computational and data science ecosystem. This ecosystem includes a 25,000+ core and 40+ petabyte usable high-performance computing (HPC) systems, clinical research databases, and a software development infrastructure for local and national projects. The HPC system is the fastest in the world at any academic biomedical center (Top 500 list).

To meet Sinai’s scientific and clinical goals, the Lead brings a strategic, tactical and customer-focused vision to evolve the ecosystem to be continually more resilient, secure, scalable and productive for basic and translational biomedical research. The Lead combines deep technical expertise in cybersecurity, HPC systems, storage, networking, and software infrastructure with a strong focus on service, collaboration, and strategic planning for researchers and clinicians throughout the organization and beyond. The Lead is an expert troubleshooter, productive partner and leader of projects. The lead will work with stakeholders to make sure the HPC infrastructure is in compliance with governmental funding agency requirements and to promote efficient resource utilizations for researchers

This position reports to the Director for HPC and Data Ecosystem in Scientific Computing and Data.

Key Responsibilities:

HPC Cybersecurity & System Administration:

• Design, implement, and manage all cybersecurity operations within the HPC environment, ensuring alignment with industry standards (NIST, ISO, GDPR, HIPAA, CMMC, NYC Cyber Command, etc.).
• Implement best practices for data security, including but not limited to encryption (at rest, in transit, and in use), audit logging, access control, authentication control, configuration managements, secure enclaves, and confidential computing.
• Perform full-spectrum HPC system administration: installation, monitoring, maintenance, usage reporting, troubleshooting, backup and performance tuning across HPC applications, web service, database, job scheduler, networking, storage, computes, and hardware to optimize workload efficiency.
• Lead resolution of complex cybersecurity and system issues; provide mentorship and technical guidance to team members.
• Ensure that all designs and implementations meet cybersecurity, performance, scalability, and reliability goals. Ensure that the design and operation of the HPC ecosystem is productive for research.
• Lead the integration of HPC resources with laboratory equipment for data ingestion aligned with all regulatory such as genomic sequencers, microscopy, clinical system etc.
• Develop, review and maintain security policies, risk assessments, and compliance documentation accurately and efficiently.
• Collaborate with institutional IT, compliance, and research teams to ensure all regulatory, Sinai Policy and operational alignment.
• Design and implement hybrid and cloud-integrated HPC solutions using on-premise and public cloud resources.
• Partner with other peers regionally, nationally and internationally to discover, propose and deploy a world-class research infrastructure for Mount Sinai.
• Stay current with emerging HPC, cloud, and cybersecurity technologies to keep the organization’s infrastructure up-to-date.
• Work collaboratively, effectively and productively with other team members within the group and across Mount Sinai.
• Provide after-hours support as needed.
• Perform other duties as assigned or requested.

Requirements:

• Bachelor’s degree in computer science, engineering or another scientific field. Master's or PhD preferred.
• 10 years of progressive HPC system administration experience with Enterprise Linux releases including RedHat/CentOS/Rocky Systems, and batch cluster environment.
• Experience with all aspects of high-throughput HPC including schedulers (LSF or Slurm), networking (Infiniband/Gigabit Ethernet), parallel file systems and storage, configuration management systems (xCAT, Puppet and/or Ansible), etc.
• Proficient in cybersecurity processes, posture, regulations, approaches, protocols, firewalls, data protection in a regulated environment (e.g. finance, healthcare).
• In-depth knowledge HIPAA, NIST, FISMA, GDPR and related compliance standards, with prove experience building and maintaining compliant HPC system
• Experience with secure enclaves and confidential computing.
• Proven ability to provide mentorship and technical leadership to team members.
• Proven ability to lead complex projects to completion in collaborative, interdisciplinary settings with minimum guidance.
• Excellent analytical ability and troubleshooting skills.
• Excellent communication, documentation, collaboration and interpersonal skills. Must be a team player and customer focused.
• Scripting and programming experience.

Preferred Experience

• Proficient with cloud services, orchestration tools, openshift/Kubernetes cost optimization and hybrid HPC architectures.
• Experience with Azure, AWS or Google cloud services.
• Experience with LSF job scheduler and GPFS Spectrum Scale.
• Experience in a healthcare environment.
• Experience in a research environment is highly preferred.
• Experience with software that enables privacy-preserving linking of PHI.
• Experience with Globus data transfer.
• Experience with Web service, SAP HANA, Oracle, SQL, MariaDB and other database technologies.

Strength through Unity and Inclusion

The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. When you join us, you become part of Mount Sinai’s unparalleled legacy of achievement, education, and innovation as we work together to transform healthcare. We encourage all team members to actively participate in creating a culture that ensures fair access to opportunities, promotes inclusive practices, and supports the success of every individual.

At Mount Sinai, our leaders are committed to fostering a workplace where all employees feel valued, respected, and empowered to grow. We strive to create an environment where collaboration, fairness, and continuous learning drive positive change, improving the well-being of our staff, patients, and organization. Our leaders are expected to challenge outdated practices, promote a culture of respect, and work toward meaningful improvements that enhance patient care and workplace experiences. We are dedicated to building a supportive and welcoming environment where everyone has the opportunity to thrive and advance professionally. Explore this opportunity and be part of the next chapter in our history.

About the Mount Sinai Health System:

Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time — discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients’ medical and emotional needs at the center of all treatment. The Health System includes more than 9,000 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status.

Equal Opportunity Employer

The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate, exclude, or treat individuals differently based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. We are deeply committed to fostering an environment where all faculty, staff, students, trainees, patients, visitors, and the communities we serve feel respected and supported. Our goal is to create a healthcare and learning institution that actively works to remove barriers, address challenges, and promote fairness in all aspects of our organization.

Cosmetic Compliance Consultant- Dental Whitening Products

Key Responsibilities:

1. Develop and lead global regulatory strategies for cosmetic and borderline products, ensuring alignment with FDA, EU MDR, and other international requirements.

2. Conduct comprehensive gap assessments against cosmetic, OTC, and product safety regulations; determine required technical documentation and assess existing files for deficiencies.

3. Prepare, review, and submit regulatory documentation, including PIFs, CPSRs, 510(k) submissions, PMAs, Technical Files, and Design Dossiers.

4. Create and manage remediation plans to close gaps in product documentation, regulatory submissions, and internal processes.

5. Evaluate regulatory impact of product, supplier, or process changes, conduct gap analyses, and coordinate necessary notifications or filings.

6. Lead audit readiness efforts, representing the organization during FDA inspections, Notified Body audits, and responding to CAPAs with robust documentation.

7. Review and approve labeling, IFUs, promotional materials, and packaging in accordance with 21 CFR Part 801, EU MDR Annex I, and cosmetic regulations.

8. Manage UDI compliance, EUDAMED submissions, PMS, vigilance reporting, and adverse event investigations per ISO 13485 and ISO 14971.

9. Act as primary liaison with FDA, Notified Bodies, and regulatory authorities; provide mentorship on regulatory intelligence and best practices.

Competency:

1. Proficient in MS Office, Excel Macros/VBA, PLM tools (e.g., Windchill), QMS platforms, and RegTech systems (MasterControl, RIMS); strong skills in Excel/SQL for data analysis and tracking.

2. Deep expertise in FDA, EU MDR/IVDR, ISO 13485, ISO 14971, regulatory intelligence, and risk management

3. Strong analytical aptitude, exceptional attention to detail, excellent stakeholder management, and advanced technical writing skills

Education/Experience:

1. Bachelor’s degree in Engineering, Regulatory Affairs, Biomedical Engineering, Life Sciences, Pharmacy, or related discipline (RAC certification preferred).

2. 8+ years of experience in cosmetic compliance with hands-on experience in dental/whitening products, borderline classifications, OTC/GPSR, safety reports, PIFs, safety assessments, and international regulatory requirements.

3. Proven ability to collaborate as a regulatory SME, delivering practical, customized compliance solutions.

Hi connections,

Role-----Test Automation Engineer with Payment Domain

Locations-----Charlotte, North Carolina, NC, United States (Hybrid)

Kindly share resumes to & Description:

We're looking for a seasoned Test Automation Engineer with deep experience in banking and payments to drive quality engineering across high‐throughput payment flows (e.g., Wires/SWIFT, FedNow, Chips, ISO 20022, ACH/NACHA, RTP). You'll design robust automation frameworks, expand test coverage across APIs/services/UI, and embed quality into CI/CD for mission‐critical systems that demand security, resiliency, and regulatory compliance.

What You'll Do

Build & Evolve Automation Frameworks

Design and maintain scalable, modular UI/API/service-level/Database automation frameworks (preferably in Java/C#/TypeScript/Python) using tools like Selenium/WebDriver, Playwright, Cypress, RestAssured, Postman.

Implement robust test data management, environment selectors, and parallel execution at scale; champion test stability (flaky test reduction).

Quality in CI/CD

Integrate test suites into CI/CD pipelines (GitHub Actions/Azure DevOps/Jenkins/GitLab CI) with gating policies, test dashboards, and quality thresholds (code coverage, pass rates, performance baselines).

Shift-left: PR-level unit/contract tests; shift-right: synthetic monitoring and observability validations post-deploy.

Payments Domain Validation

Author automation for end-to-end payment journeys: initiation → validation → routing → posting → notifications → reconciliation.

Validate file and real-time rails: Wires/SWIFT (MT/MX, ISO 20022), RTP, FedNow, Chips.

Verify message schemas (e.g., ISO 20022 pain.001/pacs.008/camt), and SWIFT MX mapping; ensure idempotency, FX/fees/tax, cut-offs, holidays, and retries.

Non-Functional & Resilience Testing

Build automation for performance, soak, and resilience (throughput/latency/error budgets, circuit breakers, back-pressure).

Execute chaos/failover/dr testing: timeouts, downstream unavailability, duplicate submissions, replay protection.

Required Qualifications

7–10+ years in test automation with 5+ years in banking/payments platforms.

Strong in one or more: Java, C#, Python, or TypeScript; hands‐on with Selenium/Playwright/Cypress and API testing (RestAssured/Postman).

Experience with message validation (JSON, XML, ISO 20022 schemas), file-based and real-time processing, asynchronous and event-driven systems (Kafka/RabbitMQ).

Solid grasp of CI/CD (Azure DevOps, GitHub Actions, Jenkins), Git, Docker/K8s, environment variables/secrets, and test parallelization.

Proven capability with SQL and at least one NoSQL (e.g., Mongo); experience setting up synthetic test data and masking strategies.

Familiarity with observability (Grafana, Splunk) to correlate test runs with system telemetry.

Understanding of SWIFT/ISO 20022, FedNow principles, fraud and risk controls, and secure coding/testing practices.

Nice-to-Have

Contract testing with schema-first approaches (OpenAPI, AsyncAPI).

Domain exposure to reconciliations, liquidity, sanctions screening (OFAC), AML, and fraud signals/decisioning.

Kindly share resumes to &

Systems Administrator with an Active Top Secret SCI/ Full Scope Poly level DOD clearance.

Description

Job responsibilities will include, but not be limited to, the following:

• Perform as a Linux System Administrator on a large government contracts.

• Perform administration on VMware technologies (or related)

• Maintain smooth operation of multi-user computer systems, including coordination with network, software, and system engineers, PC desktop technicians, project managers, end users, and customer and IT management.

• Recommend and implement system enhancements that will improve the performance and reliability of the system including installing, upgrading/patching, monitoring, problem resolution, and configuration management.

• Provide backup and recovery services; manage file systems and disk space; manage virus protection on a routine basis.

• Create and maintain user and computer accounts and modify file permissions and security access lists.

• Test new releases of products to ensure compatibility and minimize user impact.

• Develop and document technical processes and procedures as needed.

• Interact, meet, discuss, and troubleshoot issues with vendors; evaluate vendor products, services, and suggestions.

• Adhere to strict Information Systems security guidelines in all cases.

• Maintain security audit and logging information on all classified networked and standalone computers as directed by the Information Systems Security Manager (ISSM).

• Prepare security documentation for Cyber Security team.

Additional Skills & Qualifications

Preferred Qualifications

• Higher degree in a STEM-related discipline

• Security+ CE

• 5+ years of experience with Red Hat Enterprise Linux (RHEL) server administration in an SCI classified environment

• Experience with NAS storage device (preferably NetApp) administration (ONTAP 8.x or higher; CDOT)

• Solid understanding of Enterprise-level storage concepts to include all commonly used RAID-levels

• Solid understanding of remediating security vulnerabilities; Experience hardening Linux systems in accordance with RMF and STIGs

• Identity Management (Single Sign-On) experience

• VMware and ESXi (6.x or higher) configuration and management experience

• Experience with host-based firewall implementations and configuration (Redhat “iptables”)

• Windows 10 administration experience; Windows Server experience; Group Policies (GPOs) experience; Active Directory management experience

• Solid writing skills and use of Wiki pages and Sharepoint sites for documentation

• DoD 8570 Certification in a primary OS (Windows, Linux, Cisco)

• Experience in VMWare, NetApp and Splunk among other industry standard technologies. Comfortable with maintenance and OS upgrades

• Preferred candidate will be familiar with Tenable and Nessus scans for vulnerability and controls implementation.

Experience Level

Intermediate Level

We reserve the right to pay above or below the posted wage based on factors unrelated to sex, race, or any other protected classification.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. This temporary role may be eligible for the following: 

• Medical, dental & vision 
• 401(k)/Roth
• Insurance (Basic/Supplemental Life & AD&D) 
• Short and long-term disability 
• Health & Dependent Care Spending Accounts (HSA & DCFSA) 
• Transportation benefits 
• Employee Assistance Program 
• Time Off/Leave (PTO, Vacation or Sick Leave)  

Job Type & Location

This is a Contract position based out of Aurora, CO.

The pay range for this position is $50.00 - $70.00/hr.

Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Aurora,CO.

This position is anticipated to close on Mar 24, 2026.

We're partners in transformation. We help clients activate ideas and solutions to take advantage of a new world of opportunity. We are a team of 80,000 strong, working with over 6,000 clients, including 80% of the Fortune 500, across North America, Europe and Asia. As an industry leader in Full-Stack Technology Services, Talent Services, and real-world application, we work with progressive leaders to drive change. That's the power of true partnership. TEKsystems is an Allegis Group company.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

We’re a leading provider of business and technology services. We accelerate business transformation for our customers. Our expertise in strategy, design, execution and operations unlocks business value through a range of solutions. We’re a team of 80,000 strong, working with over 6,000 customers, including 80% of the Fortune 500 across North America, Europe and Asia, who partner with us for our scale, full-stack capabilities and speed. We’re strategic thinkers, hands-on collaborators, helping customers capitalize on change and master the momentum of technology. We’re building tomorrow by delivering business outcomes and making positive impacts in our global communities. TEKsystems and TEKsystems Global Services are Allegis Group companies. Learn more at .

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Notice: MCRA’s Talent Solutions division works to unite top talent with opportunities on our clients’ teams. This posting is not for a position directly at MCRA, but rather for a position with a MCRA client that our team is helping to recruit and fill.

MCRA's client, a commercial-stage medical device company specializing in designing, developing, and marketing orthopedic fracture repair and stabilization products, is in search of a Director of Quality and Regulatory Affairs to provide support across Regulatory, Quality Assurance, Operations, and Research & Development (R&D).

Primary Roles:

• Is a key member of the senior leadership, and is responsible for the successful operation of the company's quality and regulatory systems. Essential functions include the development, implementation, maintenance, and improvement of company-wide quality and regulatory systems, integrating continuous improvement activities.
• Serves as our clients Management Representative under ISO and FDA requirements, and takes the lead role in ensuring that the quality management system is efficient, effectively implemented and ensures compliance with the requirements of applicable regulatory agencies. Responsible for the generation and maintenance of our client's Quality systems, with direct oversight for the processes for Complaints Management, CAPA, Risk Management, Post-Market Surveillance, and Regulatory Reporting.
• Is responsible for leading the resolution of quality and compliance issues within the business and provide routine quality feedback and leadership to cross-functional groups
• Serves as the official correspondent to Competent Authorities (e.g. FDA, EU countries, etc) as well as Notified Body. Responsible for maintaining compliance registrations and device listings.
• Ensuring compliance with FDA and other applicable international regulations and requirements for the design, development, distribution, and maintenance of medical devices and provide general regulatory support to the organization

Responsibilities:

Quality Systems

• Provide operational leadership in planning and management of quality system activities to maintain appropriate QMS certification
• Responsible for leading and interfacing with any Notified Bodies or Competent Authorities during inquiries or facility inspections by such organizations
• Acts as lead in all product complaint and recall campaigns.
• Responsible for interfacing with and following up with any Customers regarding complaints
• Responsible for Supplier Quality assurance program
• Responsible for Measurement, analysis and improvement programs, including quality trending, CAPA system, and the Internal Quality Audit program for our client.
• Leads the Management Review process

Quality Engineering

• Ensures all inspection and quality plans are statistically sound and can ensure quality levels that exceed requirements
• Ensures all device history records are complete and reviewed prior to release of product
• Assist suppliers by providing information to enable process improvements
• Ensure all manufactured products are conforming to FDA Quality System, ISO 13485, MDD, and MDR
• Supports the engineering staff with PPQA activities, validations, and statistical analysis of new products and processes
• Leads Risk Management and Post-Market Surveillance activities

Regulatory Affairs

• Develop and implement global regulatory and compliance strategies to:
• Ensure all products designed, manufactured and/or shipped meet all regulatory, corporate and customer requirements for quality, safety and efficacy;
• Ensure proper and timely preparation and maintenance of national and international new product submissions, registration/licensing renewals, product listings, post market surveillance reports, import and export documents, safety testing, and other national and international requirement
• Optimize and focus on quality during the design and change control processes for both new and existing products;
• Ensure all advertising and promotion materials conform to applicable FDA, EU, and, where applicable, other country regulations.
• Responsible for the CE Mark approval process for all products, and Technical File generation and maintenance
• Responsible for writing Letters to File as required
• Participates in the development and writing of 510(k) submissions with the management team utilizing external resources as required
• Responsible for external agency reporting

Education:

• Bachelor’s Degree in Engineering or Natural Science preferred, coupled with approximately 10 years of combined experience in QA / RA in the medical devices industry; experience regarding medical device design, development and manufacturing regulations, especially 21 CFR Part 820 Quality System Regulation, the MDD and MDR Directives, as well as ISO 13485 requirements. 5 years of experience managing supervisory personnel and contributing toward the development of department strategies.

Experience/ Skills:

• Ability to build efficient quality assurance systems; including electronic document and record control, CAPA, NCR, complaint, training, metrics
• Demonstrated ability to write, review, execute and critique validation protocols, investigation plans, root cause analyses, NCRs, CAPAs, complaints, trend report
• Has experience with applying ISO 14971 principles to medical devices throughout all stages of the product's lifecycle.
• Demonstrated leadership skills and team building skills, inspires others toward continuous quality improvement
• Able to solve complex quality, technical, managerial or budgeting problems
• Readily adapts to changing priorities, effectively manages own time and direct reports to ensure tasks, projects are completed on time to meet growth objectives. Adjusts easily and readily to a fast-paced work environment
• Working knowledge of data acquisition, analysis and statistical software
• Demonstrated ability to manage multiple projects and technical personnel simultaneously
• Successful oral and written communication skills, business acumen and assertive decision-making ability
• Excellent computer skills, including MS Office proficiency

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization.

MCRA, LLC is an equal opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

Savino Del Bene is a Global Freight Forwarding Company headquartered in Florence, Italy. With a network of more than 295 offices and over 5,500 employees across five continents, Savino Del Bene is a leading freight forwarding company and we are currently looking for an experienced Customs Entry Writer to join our growing team. We are looking for an individual with a passion for the freight forwarding industry and customs brokerage. We are looking for TWO candidates to join our high paced team to assist in the process of clearing goods through US Customs within the United States for all import shipments in a timely, seamless and economical manner.

Essential Job Functions:

• Filing of entry/entry summaries, customer contact, electronic PGA, prior notification, electronic FCC, USDA, TSCA billing, RLF filing all over the country.
• Provide HTS to clients, ISF filing, provide clients with air and ocean import freight quotes, research for new clients, make sure files are in compliance.
• Classify all goods being imported and then request or compile the necessary documentation, including cargo-control papers, customs invoices and certificates of origin.
• Arranging for the transportation and storage of goods that have cleared customs brokers only file. Communicate with the customer service team for proper documentations.
• Know the ACE/ABI system.
• Monitor all processes and ensure compliance to all Federal regulations and custom duties.
• Coordinate with various departments and maintain compliance to all import operations.
• Prepare required documents and procedures according to company standards and ensure compliance to service requirements.
• Ensure that freight paperwork are completed and approved before transportation.
• Maintain knowledge on all industry rules and regulations and perform all custom duties.
• Uphold a strong and professional relationship with transportation agencies and sales.
• Demonstrate an emphasis on customer satisfaction per company policy
• Maintain shipment files and ensure billing is completed within a timely fashion.
• Assisting as backup for alternate accounts.
• Perform other duties as assigned.
• Must be able to work on site, this is not a remote position
• Expected to maintain conformance to ISO 9001 / ISO 14001 integrated management systems.

• Must have knowledge of the U.S. Harmonized Tariff Schedule
• Must have knowledge in food and beverage commodities as well as general commodities
• Must be able to anticipate problems and be able to liaise with governmental companies to solve them
• Must be able File and follow ISF’s
• Must have knowledge of FDA, USDA, Fish & Wildlife, EPA, and other government agencies when applicable
• Follow up with Customs and OGA, to ensure customs releases.
• Perform and Audit of the file to ensure all customs formalities have being satisfied

Preferred Qualifications

• High School Diploma or GED required.
• 2-3 years Brokerage experience
• Demonstrates excellent written and verbal communication skills
• Intermediate to Advanced PC skills - MS Office
• Highly organized
• Professional and courteous demeanor
• Displays a flexible and open minded willingness to adapt to new environments and be a team player.
• Must have good ethical standards.

Offering:

• Competitive Salary
• Great medical, dental and vision plans
• 401K with Company match
• Vacation, PTO & Sick Time
• Great Company culture, fun environment

McDonald's Works for Me.

Are you ready to take the next step in your career with a team that values your leadership, energy, and passion for people? At Iron Arch McDonald's, we're looking for dynamic, goal-oriented Shift Managers to lead our team through successful shifts while helping grow the business and develop our people.

The Job for Me This is your chance to inspire and lead. From managing day-to-day operations to mentoring team members and ensuring exceptional customer experiences, this role is about making an impact.

The Team for Me Are you a team player who thrives on energy and purpose? Do you enjoy coaching, solving challenges, and working in a fast-paced environment that delivers feel-good moments to guests? If so, you'll fit right in.

The Company for Me Iron Arch McDonald's offers more than just a job; it's a career with opportunities to grow, lead, and build a future. With competitive pay, world-class training, and benefits that matter, we're here to help you succeed.

What You'll Do

As a Shift Manager, you will:

• Lead shifts to ensure customers receive fast, accurate, and friendly service.
• Provide leadership to crew and managers during shifts, focusing on Quality, Service, and Cleanliness.
• Plan, monitor, and adjust operations to meet McDonald's standards and goals.
• Monitor safety, security, and profitability throughout your shift.
• Communicate effectively with the next Shift Manager to ensure smooth transitions.
• Support assigned Departments by helping meet team goals and targets.

You'll also be responsible for:

• Food Safety: Maintaining high standards and compliance with all procedures.
• Internal Communication: Keeping the team informed and motivated.
• Inventory Management: Monitoring and managing stock levels.
• Daily Maintenance and Cleanliness: Ensuring the restaurant is always guest-ready.
• Crew Management: Coaching, supporting, and leading team members.
• Quality Food Production: Ensuring food is prepared to the highest standards.
• Exceptional Customer Service: Creating memorable guest experiences.
• Safety and Security: Prioritizing the safety of guests and team members.
• Scheduling and Training: Supporting team development and operational excellence.

What We're Looking For

Our ideal candidate:

• Leadership Experience: Previous leadership experience is preferred, ideally in restaurants, retail, or hospitality.
• Team Player: Positive, flexible, and passionate about working in McDonald's fast-paced environment.
• Goal-Oriented: Focused on delivering results and building a great team.
• Must be 18 years or older.

Perks and Benefits

We believe in taking care of our team, and that includes incredible benefits:

• Paid Time Off: Earn PTO while growing your career.
• Education Opportunities: Access to Archways to Opportunity, including tuition assistance, high school completion programs, and English language classes.
• Health Coverage: Comprehensive medical, dental, and vision insurance.
• Retirement and Savings: Pre-tax flexible spending accounts and more.
• Additional Benefits:
• Paid leaves of absence.
• Short- and long-term disability, life, and accident insurance.
• Service awards and career recognition.

Why Iron Arch McDonald's?

This isn't just a job it's your chance to lead, grow, and make a difference. Let's talk. Make your move.

Apply today to join our team of leaders who are going places!

Wages Starting at $15 an hour

This job posting contains some information about what it is like to work in a McDonald's restaurant, but it is not a complete job description. People who work in a McDonald's restaurant perform a number of different tasks every day, and this posting does not list all of the essential functions of this job.

By applying to this position, I understand that I am applying to work at a restaurant that is owned and operated by an independent franchisee, not McDonald's USA. I understand that this franchisee is a separate company and a separate employer from McDonald's USA. Any information I provide in this application will be submitted only to the independent franchisee, who is the only company responsible for employment matters at this restaurant. I recognize that the independent franchisee alone will make all decisions concerning employment matters, including hiring, firing, discipline, supervision, staffing and scheduling. By applying for a job at a franchisee operated restaurant, I understand that the information I provide will be forwarded to the franchisee organization in order for that organization to reach out to me and process and evaluate my application. I acknowledge that McDonald's USA will not receive a copy of my employment application and will have no involvement in any employment decisions regarding me, including whether I receive an interview or whether I am hired to work for the franchisee. I understand that I need to contact the franchise organization for information about its privacy practices.

• Location: Boston, MA
• Hybrid: 3 days on site
• Potential Convert: Yes, USC/GC ONLY no exceptions. WILL NOT SPONSOR

• ETL/ELT
• ODI
• PL/SQL coding
• 7 years’ experience
• Knowledge on how to be an admin side of things (not day to day but is able to do that)
• Scripting – Python & Unix Scripting

• Build ODI mappings/interfaces, packages, procedures, scenarios, topology configuration, ODI Agent and load plans to integrate data from multiple enterprise systems.
• Expertise in building Pl/SQL queries, procedures, data loading process, ensuring high-performance and scalability to meet the evolving data needs of the various applications.
• Design, develop, and maintain ETL/ELT pipelines using Oracle Data Integrator (ODI).
• Collaborate effectively with cross-functional teams, including other data engineers, DBA group, analysts, and business stakeholders, to understand data requirements and deliver solutions.
• Monitor and troubleshoot RMJ jobs, ODI workflows, sessions, agents, and data pipelines on Linux environments.
• Perform root cause analysis for failures related to ODI workflows, RMJ jobs, network connectivity, API integrations, and file transfers.
• Optimize ETL workflows to improve reliability, performance, and scalability.
• Use scripting and automation tools to support data processing and operational workflows.
• Work in Linux/Unix environments, using command-line tools and shell scripts for job automation and troubleshooting.
• Maintain comprehensive documentation of data processes, configurations, and best practices.
• Participate in walk-throughs which review program specifications, source code, and all technical supporting documentation, including screens/reports. Provide feedback in accordance with team standards and guidelines.
• Participate in implementation of changes, enhancements, and newly developed programs.
• Conduct technical research and provide recommendations, develop proofs of concept or prototypes, contributing to technical design of applications.
• Helping to identify coding patterns and anti-patterns and enforce implementation of the patterns through code reviews.
• Quickly resolving issues encountered by business lines in the production environment, maintaining a helpful, "high touch" approach to working with business users, performing root cause analysis, technology evaluation, and performance tuning.

Desired Qualifications:

• Degree in Computer Science, Engineering or related technical area
• 7+ years of extensive hands-on experience in ODI, Oracle Datawarehouse, Oracle PL/SQL, Linux, Python scripting, and ODI admin module (ODI Agent setup, logs configuration, certificate installation).
• Must have experience in building Pl/SQL queries for Oracle Server (incl. stored procedures, functions…) and must understand basic principles of data modeling
• Excellent collaborative and communication skills, particularly in high-stress situations
• Experience with scripting Python and Linux scripting, CLE, networking fundamentals (API, IP/ports, SFTP/FTP connectivity)
• High proficiency in development practices: unit testing, Continuous Integration (CI/CD), refactoring, clean code
• Experience with Bitbucket/GIT source control management
• Problem solving skills, able to determine upcoming risks & issues and address them accordingly.
• Ability to interpret and troubleshoot applications using logs.
• Pro-active approach and good communication skills.
• Experience with agile methodologies (Scrum, Kanban) and tools (Jira)

• Private Banking domain experience.
• Working experience in a financial service industry
• Financial application knowledge like FIS AddVantage, CRD, CRM Pivotal.
• Experience with Apache Airflow for workflow orchestration.
• Knowledge of dbt (Data Build Tool) for modern data transformations.
• Exposure to cloud data platforms or hybrid data architectures.

Key Competencies:

• Strong analytical and problem-solving skills
• Ability to work with large-scale enterprise data environments
• Excellent collaboration and communication skills
• Ability to manage multiple priorities in a fast-paced environment
• Commitment to continuous learning and technology innovation

Estimated Min Rate: $55.00

Estimated Max Rate: $72.00

What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh’s hiring clients’ preferences. To learn more about Yoh’s privacy practices, please see our Candidate Privacy Notice:  working/work at home options are available for this role.