Arch Linux Arm64 Iso Jobs in Usa

About Company:

Who Are We?

ELIQUENT Life Sciences is a leading global consulting group delivering regulatory affairs, pharmacovigilance, quality, and compliance solutions that support pharmaceutical, biotechnology, medical device, and combination product companies across therapeutic modalities, phase-based pathways, and major global markets.

Why explore your future at ELIQUENT?

ELIQUENT Life Sciences is a trusted global consulting firm helping life sciences companies navigate regulatory complexity and bring breakthrough therapies to market. Founded by former regulators and industry experts, we offer end-to-end support in regulatory affairs, pharmacovigilance, and quality compliance. Our team is driven by a shared mission to improve global health through innovation, collaboration, and integrity. At ELIQUENT, you will be part of a purpose-led organization where your expertise contributes to meaningful impact and your growth is supported every step of the way.

About the Role:

The Process Validation Engineer plays a critical role in ensuring that manufacturing processes consistently produce products that meet predetermined quality standards and regulatory requirements. This position involves designing, executing, and documenting validation protocols to confirm that processes operate within defined parameters and yield reliable, reproducible results. The engineer collaborates closely with cross-functional teams including manufacturing, quality assurance, and regulatory affairs to identify process risks and implement corrective actions. By analyzing process data and trends, the engineer supports continuous improvement initiatives that enhance process efficiency and product quality. Ultimately, this role ensures compliance with industry standards and contributes to the successful commercialization of products within the United States market.

Minimum Qualifications:

• Bachelor’s degree in Engineering, Science, or a related technical field.
• 3+ years of experience in process validation within a regulated manufacturing environment.
• Strong knowledge of validation principles, methodologies, and regulatory requirements (e.g., FDA, cGMP, ISO).
• Experience with statistical analysis and process capability studies.
• Excellent written and verbal communication skills.

Preferred Qualifications:

• Master’s degree in Engineering, Quality Assurance, or related discipline.
• Experience in the pharmaceutical, biotechnology, or medical device industries.
• Familiarity with automation systems and computerized system validation (CSV).
• Certification in Quality or Validation (e.g., ASQ Certified Quality Engineer).
• Proficiency with data analysis software such as Minitab or JMP.

Responsibilities:

• Develop, review, and execute process validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Collaborate with manufacturing and quality teams to identify critical process parameters and quality attributes.
• Analyze process data to assess process capability and identify areas for improvement.
• Prepare detailed validation reports and maintain comprehensive documentation in compliance with regulatory standards such as FDA and ISO.
• Support investigations related to process deviations, non-conformances, and implement corrective and preventive actions (CAPA).
• Participate in risk assessments and process design reviews to ensure robust and compliant manufacturing processes.
• Train and mentor manufacturing personnel on process validation requirements and best practices.

Skills:

The Process Validation Engineer utilizes analytical skills daily to interpret complex process data and ensure manufacturing consistency. Strong communication skills are essential for collaborating with cross-functional teams and documenting validation activities clearly and accurately. Technical expertise in validation protocols and regulatory standards guides the development and execution of robust validation plans. Problem-solving skills are applied to investigate deviations and implement effective corrective actions. Additionally, proficiency with statistical tools and software supports data-driven decision-making and continuous process improvement.

Job Summary:

The Maintenance Planner’s primary job function is to plan and coordinate activities for the Maintenance Department. Drives to maintain the work order backlog at an acceptable level and works with other team members in the department to minimize unplanned production downtime.

Essential Functions:

1. Plan and coordinate activities for the Maintenance Mechanics: PM’s, Work Orders, Project Work,

etc. using CMMS software (Limble)

• Serves as Primary Administrator of the CMMS software (Limble)
• Coordinate with Maintenance Clerk on procurement and kitting of parts for planned work.
• Maintain and improve Adhesives Research manufacturing facilities, support systems and equipment.
• Support change controls and capital projects in conjunction with Quality, Operations, Process Engineering, and Project Engineering.
• Lead, facilitate, and champion process optimization and continuous improvement projects designed to promote top line growth opportunities through: equipment reliability, PMs, work order closures, and safety improvements
• Self-motivated and self-disciplined with the ability to work independently and with minimalsupervision

1. Write change controls as required per SPAR 7233
2. Write planned deviations and non-conformances for PM’s as needed
3. Supports the area managers and supervisors with key metrics, identifies and implements continuous improvement actions; makes identifiable and substantial contributions to improving equipment reliability, PMs, and facility cleanliness
4. Interface with external equipment vendors, engineering companies, contractors, and customers
5. Ability to handle multiple projects concurrently
6. Represent the organization in a professional and positive manner to associates, external customers, and vendors
7. Conform to Company policies and procedures, Quality Systems, cGMPs, ISO, OSHA, etc.
8. Perform and/or support maintenance duties as needed.
9. Coordinate engineering capital projects as well as contractor work projects
10. Ensures compliance with all relevant regulations (e.g. ISO, FDA, OSHA, EPA, DEP, etc.) and company procedures

Additional Responsibilities:

• Performs other duties and responsibilities as assigned.

Job Specifications:

• Minimum of a high school diploma or equivalent
• Strong background in maintenance planning/coordinating work flows
• Previous maintenance supervisory experience a plus
• Minimum of 10 years experience in maintenance
• Experience / knowledge of Lean Manufacturing practices and principles
• Experience with Computerized Maintenance Management System (CMMS)
• Strong mechanical aptitude and analytical ability
• Computer literacy with good working knowledge in Excel, Word, and PowerPoint

Job Purpose

The objective of this position is to drive and nurture a culture of safety throughout the plant. This includes all aspects of safety compliance and development of policies, instructions, procedures and systems within the Environmental Health and Safety Management System.

Duties and Responsibilities

• Advise management of current regulatory requirements and industry standards
• Ensures current and ongoing safety compliance of the plant
• Liaison between safety and environmental on common issues
• Provide critical review of health and safety incident reports and ensures corrective actions are completed correctly and in a timely manner
• Coordinate special safety meetings
• Provide training as requested or required
• Conduct housekeeping and safety audits
• Serve as a member/leader of safety teams as assigned
• Manage incident reports and assists managers/supervisors with investigations
• Assist with the management of the Emergency Response Team

Qualifications

• Bachelor’s degree or equivalent of 5 – 7 years’ experience as safety professional
• Minimum of 1 year experience in a manufacturing environment
• Experience working in the aluminum industry a plus
• Proficient skills in Microsoft Office
• Comfortable with conducting training sessions and presentations
• Able to work extra hours and on weekends if required
• Willing to travel (5%) among various locations
• Knowledge of OSHA, NIOSH IH and NFPA standards with willingness to advance knowledge

Physical Demands

• This is an on-site position – remote work is not available
• Must successfully pass a rigorous medical examination
• Medically certified for respirator use
• Must have no limitations to walking, standing, climb and balance, stoop or kneel
• Able to lift 10 to 25 pounds
• Able to withstand extreme weather conditions – heat, cold, rain
• Additional Responsibilities
• Follow guidance from ISO coordinators regarding compliance with ISO registrations
• Abide by all company policies, practices and rules
• Participate in continuous safety improvements

What You’ll Do:

• Audit Safety Control Systems (SCS) for compliance with ISO 13849 & ANSI B11
• Identify non-conformities and implement countermeasures to achieve required performance levels
• Develop project plans, milestones, KPIs, and manage 3rd-party consultants
• Lead cross-functional collaboration and provide executive-level status reporting
• Support troubleshooting, implementation, and mentorship of technical teams

Must-Have Qualifications:

• TÜV Functional Safety Engineer (or equivalent certification)
• 5+ years in functional safety within industrial/automation environments
• Strong Safety PLC programming and communication protocol experience
• Hands-on experience with ISO 13849-1, ANSI B11 compliance

Preferred Experience:

GuardLogix, Omron Sysmac Safety, Siemens TIA Portal (Safety), FMEA/FMEDA, and risk assessment tools.

"Candidates must be authorized to work in the United States without the need for current or future visa sponsorship."

Role Overview

We are seeking a highly motivated and experienced GRC Manager to lead and mature our cybersecurity governance, risk, and compliance program across a complex retail ecosystem supporting 60,000+ associates, thousands of brick-and-mortar stores, distribution centers, corporate offices, datacenters, and multi-cloud environments.

This role will play a critical part in supporting our ongoing divestiture and Transition Services Agreement (TSA) journey initially, helping establish independent governance structures while ensuring continued alignment with shared services and transitional operating models.

The GRC Manager will partner closely with internal stakeholders, legacy service providers, and Business Process Outsourcing (BPO) partners to ensure risk visibility, compliance assurance, and control ownership clarity across both transitional and steady-state environments.

The ideal candidate is both strategic and execution-oriented, capable of operating effectively in environments undergoing transformation while building scalable governance frameworks for the future state.

Key Responsibilities

Governance & Program Leadership

• Lead the enterprise cybersecurity governance framework aligned to NIST CSF / NIST 800-53 / ISO 27001.
• Support the design and maturation of governance structures as the organization transitions through TSA toward a standalone operating model.
• Own and maintain the cybersecurity policy, standards, and control framework lifecycle.
• Establish governance forums and reporting cadence with executive leadership.
• Drive maturity roadmap aligned to organizational risk appetite and separation milestones.
• Ensure governance processes are embedded across internal teams, TSA providers, and BPO partners.

Risk Management

• Manage the enterprise cyber risk program including risk identification, assessment, treatment, and reporting.
• Assess risks related to shared services, transitional architectures, and separation activities.
• Facilitate risk assessments across cloud, retail stores, supply chain, datacenters, and enterprise applications.
• Maintain enterprise risk register and track remediation progress across internal teams, TSA providers, and BPO partners.
• Partner with architecture and engineering teams to embed risk-based decision making during separation initiatives.

Compliance & Regulatory Oversight

• Lead compliance efforts across relevant frameworks including:
• PCI DSS
• SOX ITGC
• Privacy / Data Protection requirements
• State and federal regulatory obligations
• Support compliance activities during TSA including shared control environments and inherited controls.
• Coordinate internal and external audits and manage evidence collection.
• Ensure continuous compliance monitoring across environments including controls operated by TSA and BPO providers.
• Validate adherence to contractual security and compliance obligations.

Third Party & TSA Risk Management

• Oversee vendor risk assessments across SaaS, supply chain, TSA providers, and service partners.
• Serve as the primary GRC liaison for cybersecurity BPO providers and transitional service providers.
• Monitor vendor, TSA, and BPO risk posture, performance metrics, and remediation activities.
• Partner with procurement and legal on risk reviews and contractual security requirements.

BPO Governance & Oversight

• Establish governance cadence with BPO partners including operational reviews and risk forums.
• Define and monitor security KPIs/KRIs and SLAs tied to BPO services.
• Ensure clear accountability and control ownership between internal teams, TSA providers, and BPO.
• Support continuous improvement initiatives with BPO providers to enhance control maturity.

Metrics, Reporting & Executive Communication

• Develop and maintain cyber risk dashboards and KPIs/KRIs aligned to separation milestones.
• Provide regular reporting to executive leadership and governance councils.
• Translate technical risk into business impact for decision making.

Cross Functional Collaboration

• Partner with Security Operations, Engineering, Privacy, Legal, Internal Audit, and IT.
• Support secure transformation initiatives including cloud migration and retail technology modernization.
• Provide governance support for separation programs and new capability buildouts.
• Drive security awareness from a governance and risk perspective.

Required Qualifications

• Bachelor’s degree in Cybersecurity, Information Security, IT, Risk Management, or related field.
• 7–8 years of experience in cybersecurity, risk, compliance, or audit roles.
• Experience operating in a large enterprise environment with distributed infrastructure.
• Experience supporting transformational programs, divestitures, or large-scale operating model changes.
• Experience working with or overseeing BPO / managed service providers in a cybersecurity or IT risk capacity.
• Strong understanding of cybersecurity frameworks (NIST CSF, ISO 27001, COBIT).
• Experience supporting regulatory audits (PCI, SOX, privacy).
• Experience with risk management methodologies and control frameworks.
• Strong stakeholder management and communication skills.

Preferred Qualifications

• Experience in retail, logistics, or highly distributed environments.
• Experience supporting multi-cloud environments (AWS, Azure, GCP).
• Professional certifications such as:
• CISSP
• CISM
• CRISC
• CISA
• Experience with GRC platforms (ServiceNow GRC, Archer, OneTrust, Auditboard etc.).
• Experience working in TSA or shared services environments.

Leadership Competencies

• Strategic thinker with strong execution discipline
• Ability to operate effectively in ambiguous and evolving environments
• Strong analytical and problem-solving skills
• Executive presence and communication ability
• Collaborative and people-focused leadership style
• Strong vendor and partner management capability

Job Title: Call Center Manager

Location: Charleston, SC

Position Overview:

We are seeking a Customer Service Manager with 6-8 years of experience in customer service operations and 3-5 years in a management role. The ideal candidate will have deep knowledge of supply chain processes, logistics, and customer service strategies, with a focus on driving team performance and ensuring customer satisfaction. Experience in textile manufacturing and knowledge of SAP, MRP/ERP systems, and ISO standards are highly preferred.

Key Responsibilities:

• Lead and motivate a performance-driven customer service team to meet business goals.
• Manage customer service operations to ensure high-quality service and meet global/regional/local targets (Sales, Inventory, OTIF).
• Deep knowledge of reverse logistics, order management, and customer service strategies.
• Oversee inventory costing and transactions, driving improvements in inventory management.
• Ensure customer satisfaction by understanding customer needs and addressing issues proactively.
• Ensure compliance with EHS, ethics, and operational standards.

Key Requirements:

• Bachelor's degree in Supply Chain Management, Business Administration, or related field.
• 6-8 years of customer service experience, with 3-5 years in a management role.
• Strong communication and presentation skills.
• Expertise in MRP/ERP, SAP knowledge preferred.
• Experience with ISO 9000, TS16949, SOX, and logistics/transportation.
• Textile manufacturing experience is a plus.

Key Competencies:

• Decision making and adaptability
• Situational influencing and organizational commitment
• Achievement orientation and customer focus

If you have the experience and skills to manage a dynamic customer service team and drive operational excellence, we encourage you to apply!

What We Need:

The Customer Service Supervisor directs and enables staff to execute reliable and consistent support to meet customer needs, achieve business and team objectives, and attain goals and forecasts. This position manages individual performance and professional development for 20-25 direct reports including coaching, development, performance and progressive disciplinary actions as needed. They are responsible for providing leadership, driving continuous improvement, maintaining standards and delivering a best in class customer experience. Upholds organizational policies and procedures and sets general direction for their team by creating and encouraging a work environment consistent with Brady values and competencies.

What You Will Be Doing:

• Responsible for team performance, development and attainment of all KPI results
• Understand customer needs and expectations to enable support and mitigate challenges
• Adapt plans and priorities to address resource and operational challenges
• Ensure customer follow up and resolution to inquiries and challenges
• Proactively prevent issues anticipating concerns and identifying broader implications
• Conduct problem solving and resolution in common day to day operations
• Identify process gaps and lead ongoing process and service improvements
• Manage all call, email and quality monitoring systems
• Responsible for successful hiring and onboarding new employees
• Ensures timely and accurate SAP transaction and system information is maintained, updated and readily available for team; including standard work, auditing, knowledgebase
• Strategically utilize and develop procedures and processes to meet business objectives
• Performs advanced and diversified assignments
• Run and analyze department reporting to ensure integrity and drive continuous improvement
• Monitor team metrics and direct corrective actions to ensure targets are achieved
• Recommend, implement, and communicate changes/solutions to systems, policies, or processes.
• Actively collaborate across departments to monitor efficiencies and direct efforts to improve cross functional processes and outcomes.
• Maintain all compliance standards for SOX, ISO, PCI, and AS9100
• Participate in SOX, ISO, PCI and AS9100 audits
• Conduct standard work auditing to ensure adherence coaching to opportunities
• Responsible for writing and delivering performance reviews and recommending pay increases

What You Will Need To Be Successful:

• Bachelors degree
• Strong professional verbal, written, and interpersonal communication skills
• Ability to deal with ambiguity and work autonomously
• Ability to build effective teams
• Effective time management and organizational skills
• Ability to work under pressure and make decisions autonomously
• Ability to work with all levels of the organization
• Ability to multitask, meet/exceed deadlines, and execute project ownership
• Strong attention to detail in a highly dynamic and changing environment
• Ability to develop others through a variety of methods
• Presentation skills and ability to facilitate discussions in a large group setting
• Ability to optimize work processes by identifying and driving departmental strategic initiatives
• Ability to lead a high visibility, cross-functional project
• Self-aware of own strengths and opportunities and takes ownership of individual development
• Ability to think critically to understand how problems impact all areas of the organization
• Understands different learning styles and the need to adapt communication/style

Pave Talent is hiring on behalf of our client, a 65,000 sq ft food manufacturing facility in Memphis with 58-60 employees. This plant produces yeast products for the baking industry and is part of a global ingredients company backed by a Fortune 500 parent organization. The facility has recently brought in new leadership (new plant manager, new EHS manager, new HR) and is focused on continuous improvement and quality excellence.

THE OPPORTUNITY

You'll report to the Quality Manager and work alongside a team of 8 lab technicians who are currently cross-trained in micro but need your expertise. This is your chance to own the microbiology function at a facility that's investing in doing things right.

The Quality Manager said it directly: \"We need someone with a strong microbiology background who can develop plans and investigations, not just execute tasks. We want to take this position to the next level.\"

WHAT YOU'LL BUILD

You'll split your time across four core areas:

Testing and investigative work (60% of your time) Contamination analysis, developing micro investigative plans, understanding sources of contamination, and leading root cause analyses

Media preparation and supply management (20%) Ensuring you have everything needed for analysis and maintaining proper supplies

Culture management (10%) Seed culture management and inoculation, at least once per week

Oversight and competency verification (10%) After you're established, ensuring the existing lab technicians are competent and consistent in how they handle micro responsibilities

Other key responsibilities include:

Develop and manage proactive monitoring plans for plant microbiological health Monitor compliance with food safety and quality regulations Serve as the subject matter expert for plant sanitation programs Enhance the Environmental Monitoring program through risk assessments and data analysis Support HACCP programs and plant audits (FDA, SQF, ISO, customer audits) Prepare all media used for microbiological analysis Lead investigations and corrective actions for any micro-related deviations

WHAT MAKES THIS DIFFERENT

Food manufacturing is not pharma. The Quality Manager was clear about this: \"Pharmaceutical is a little bit cleaner and structured. Manufacturing requires someone who can react to changes in environment or situations during the process. It's not always going to be black or white.\"

Translation: This role requires adaptability. You're not working in a pristine, highly controlled lab. You're working in a manufacturing plant where things change, and you need to be comfortable with that variability while maintaining food safety standards.

REQUIRED QUALIFICATIONS

Bachelor's degree in Microbiology required (not biology with micro coursework - actual microbiology degree, they need the theoretical foundation) 3 to 5 years of microbiology lab experience OR food manufacturing experience Food manufacturing experience strongly preferred over pharma or biotech (they need someone comfortable with manufacturing variability, not just clean room protocols) Available to work core hours Monday through Friday (7:00 AM to 3:30 PM or 8:00 AM to 4:30 PM) with flexibility Weekend work at least once per month to support this 24/7 operation (especially during initial training period to ensure technicians are competent with weekend testing)

BONUS QUALIFICATIONS

Fermentation experience (doesn't have to be yeast-specific, but fermentation background is ideal) SQF Practitioner certification and audit experience HACCP training or PCQI certification Experience developing and managing sanitation programs in food manufacturing Experience with GFSI, ISO, Kosher, NGP, or Organic certification programs

COMPENSATION AND BENEFITS

Base Salary: $80,000 to $90,000 (flexibility up to approximately $95,000 for exceptional candidates with extensive food manufacturing micro experience)

Bonus: 5% annual bonus (this is a grade level comparable to supervisor, not a stretch goal)

Schedule: Monday through Friday, core hours 7:00 AM to 3:30 PM or 8:00 AM to 4:30 PM. Some flexibility on weekday hours, but driven by testing and incubation cycles. Weekend work required at least once per month to support the 24/7 operation.

Benefits: Medical, dental, vision, 401(k) (benefits details available during interview process)

Relocation: Open to relocating the right candidate

Location: Memphis, TN (2743 Riverport area)

THE INTERVIEW PROCESS

Phone screen with the HR Generalist at the Memphis plant Virtual interview with the Quality Manager, Yeast Technologist, and Director of Yeast Technology Final on-site interview at the Memphis facility

Interested? Apply via LinkedIn and we'll be in touch. Confidential search; your application is fully private.

Do you have a passion for helping design and manufacture innovative medical and drug delivery devices that can improve lives? At Gilero’s Pittsboro, NC location, we are looking for a Design Transfer Engineer to help lead our mission-driven team with purpose and dedication, fostering inclusivity and teamwork to create innovative solutions for patients and customers.

Design Transfer Engineers draw on experience to oversee and champion the development and production of medical devices and combination devices, focusing on idea generation, verification, validation, and DHF development to state-of-the-art requirements.

In this role, you would manage technical risks and ensure high-quality outcomes, ensuring seamless collaboration with customers, vendors, and internal teams. You would also mentor junior engineers, promoting excellence and future success. The work of a Senior Design Transfer Engineer should have a sense of pride, characterized by curiosity, attention to detail, and organizational excellence.

Responsibilities

• Act as a technical support, increasing the rigor of technical product development, with project support of products, accessories, and cross-functional initiatives
• Manage product development deliverables through the entire development lifecycle, with a focus on manufacturing transfer
• Support sustaining engineering activities for products in commercial manufacturing
• Write and execute protocols to assess manufacturing process capability (IQ/OQ/PQ)
• Maintain Device Master Record (DMR) and ensure documents are complete, accurate, and current including process routers, inspection plans, temporary deviations, and nonconformances
• Participate in manufacturing investigations/CAPA resolutions to identify improvements to the manufacturing processes
• Support the quotation process for engineering projects and commercial manufacturing
• Facilitate design transfer of existing products to and from other manufacturing sites
• Track technical risk and provide engineering guidance
• Seek feedback and mentorship from senior engineers
• Help lead the development team through technical risk retirement. Support the team on technical risks through step-by-step simplification to discover root cause
• Create, review, and release documents according to Gilero’s QMS and the lifecycle of the project and develop test methods and protocols to fulfill state of the art requirements
• Keep project managers informed on technical projects variables and status
• Prepare documentation to support design history files and regulatory submissions
• Analyze test data, interpret results, formulate conclusions, and apply statistical techniques (t-test, ANOVA, UCL/LCL, Tolerance Intervals)
• Draft Risk documentation through understanding of Risk, Risk analysis, & Risk Burn Down
• Support delivery of project objectives and milestones
• Participate in testing campaigns, test flows, sample size analysis, and justification, based on sound judgment, Risk analysis, and QMS requirements
• Support product and process risk assessments, including hazard analysis, FMEAs and residual risk analysis in conjunction with Quality Engineering
• Write and execute protocols for design verification and validation
• Support test method development and validation
• Oversee and perform testing and inspection of prototypes and pre-production products including assisting assembly for DV&V builds and clinical builds
• Support investigation of device failures, coordinate resources, determine root cause, identify corrective actions, and document in conjunction with Quality Engineering
• Investigate, evaluate, and research competitive devices and product materials/designs

Skills/Qualifications:

• BS in Engineering or equivalent technical degree
• 1+ years relevant working experience in product development, 2+ preferred. Medical device or combination product experience preferred
• Skilled at transforming technical situations into well-defined project deliverables
• Understanding of good GDP
• Understanding of the Phase Gate System
• Exposure and understanding of ISO 14971, 13485 and CFR 21 Knowledge base
• Ability to translate User Needs/Requirements into measurable technical/product requirements and set appropriate specification though thought experiments and empirical testing
• Ability to support and document appropriate scenarios for rationale-based decisions versus testing-based approaches
• Ability to author scientific/logic-based rationale
• Awareness of pre-clinical validation and GLP
• Ability to review and understand technical drawings and GD&T to support development lifecycle
• Ability to review, understand, and distill technical standards (ISO, ASTM, IEC, etc)
• Excellent communication skills (oral and written)

Personal Attributes:

• Meets Gilero Core Values:
• Collaboration - embracing teamwork and transparency in our organization, partnering with our customers and vendors
• Integrity - doing the right thing at all times; fair and trustworthy; always keeping the patient in mind
• Innovation - open to new ideas, processes, and solutions; leveraging technology to creatively solve problems
• Excellence - delivering exceptional products and services with passion and pride
• Comfortable and productive in a fast-paced, entrepreneurial environment
• A self-starter seeking a career opportunity with potential for internal advancement, seeking
• responsibility for core activities and providing high-quality service to internal and to external clients
• Commitment to excellence and quality service to external and internal customers
• Follow established policies and procedures, while contributing to continuous improvements

Eligibility To Work:

• Applicants must be permanently authorized to work in the United States without the need for employer sponsorship now or in the future.
• Gilero does not offer sponsorship for employment authorizations (work visas).
• We are an E-Verify employer and confirm work authorization for all new hires.

Why work at Gilero?

Founded in 2002, Gilero, a Sanner Group company, is an international contract engineering firm that specializes in the design, development, and manufacturing of novel medical devices and drug delivery products. At Gilero, we are proud of the culture we have built that directly reflects our values of excellence, integrity, innovation, and collaboration. Motivated by our purpose to benefit people and improve patient outcomes, our team continues to grow at a rapid pace. US locations include Carlsbad, CA; Chicago, IL; as well as NC locations in Raleigh, Durham, Greensboro, and Pittsboro.

You will enjoy an annual bonus plan, Medical (3 BCBS plans to choose from), dental and vision, company-provided life insurance, short-term and long-term disability, 401(k) with a match the first month you start with a zero-vesting period, and access to LinkedIn learning for personal and professional development.

Featured benefits

• Medical insurance
• Vision insurance
• Dental insurance
• 401(k)
• Paid maternity leave
• Paid paternity leave
• Disability insurance

Design Assurance Engineer

Location: Wilmington, Delaware

About Our Client:

Our Hiring Company, a best-in-class Medical Device Manufacturer has an opening for a new team member at their facility. Holding itself to the highest standards of integrity, quality and excellence, this company has contributed to the healthcare industry for over 90 years and has been rated as Forbes top 14 most innovative companies in the world. With a strong vision for making medical treatments easier on its patients, this company gears its technological innovations from its top-talented engineers towards making a significant contribution to our society.

Key Responsibilities:

• Representing Quality on product development teams to ensure compliance with internal procedures and U.S. and international regulatory requirements.
• Leading quality system development and implementation throughout the product lifecycle.
• Providing focused quality engineering support and driving timely execution of assigned project activities.
• Leading Risk Management activities, including authoring risk management plans and reports, facilitating FMEA sessions, and ensuring risk assessments occur at appropriate project phases.
• Leading master validation planning sessions and reviewing/approving validation and qualification documentation.
• Reviewing and approving technical transfer plans and supporting design transfer activities to manufacturing
• Providing input to material specifications, drawings, inspection procedures, and manufacturing documentation to ensure manufacturability and testability.
• Overseeing metrology, incoming inspection, acceptance criteria, and disposition of non-conforming materials.
• Participating in supplier selection and component specification reviews, and acting as a technical quality liaison for supplier-related issues.
• Developing and validating quality test methods.
• Establishing and leading corrective and preventive action (CAPA) plans and quality assurance strategies
• Reviewing quality history, supplier controls, scrap analysis, and process controls to drive defect prevention initiatives.
• Monitoring field quality performance, analyzing field returns, and determining root cause.
• Tracking quality trends, managing corrective actions, and driving continuous improvement efforts
• Generating and maintaining quality documentation including quality plans, SOPs, and inspection procedures.
• Participating in Product Review Boards and leading investigations into internal and external complaints
• Applying structured problem-solving methodologies to identify, prioritize, and resolve quality issues
• Providing training and mentorship on quality system processes and best practices.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline required.
• 4–6 years of experience in Product Development or R&D within a regulated environment.
• 6–10 years of progressive experience in a medical device quality assurance environment.
• Strong working knowledge of engineering fundamentals and their application in product development and manufacturing.
• Auditor experience preferred (1–2 years).
• Demonstrated knowledge of 21 CFR 820, ISO 13485, ISO 14971, and other applicable medical device regulations and standards.
• Experience with quality tools and statistical methodologies including FMEA, DOE, SPC, and Minitab.
• Experience supporting validation, design transfer, and risk-based change control processes.
• Strong analytical, mathematical, and statistical capabilities.
• Excellent computer proficiency.

Interested Candidates please apply on our website at

For more information about our services and great opportunities at JBL Resources, please visit our website:

JBL Resources is proud to have earned the reputation of being a premier provider of top talent professionals in the fields of engineering, human resources, logistics, operations, and supply chain management. As specialists in both permanent placement and contract services, our mission is to help companies and individuals become all they were created to be.

**JBL is an Equal Opportunity Employer and E-Verify Company