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Job Title: Director of Quality Assurance – Tissue Processing
Location: San Antonio, Texas, USA
Department: Quality Assurance / Regulatory Affairs
Reports To: Executive Leadership
FLSA Status: Exempt
Position Summary
The Director of Quality Assurance is responsible for providing strategic leadership, direction, and oversight to the company’s Quality Management System (QMS) to ensure compliance with international and domestic tissue processing regulations, standards, and corporate policies. This role establishes quality strategy, directs organizational compliance programs, and ensures alignment with corporate objectives across all quality assurance processes, including regulatory compliance, internal and external audits, risk management, supplier quality, and continuous improvement initiatives. The Director of Quality Assurance serves as a key member of the leadership team, providing executive-level guidance on quality strategy and regulatory risk management, ensuring the delivery of safe and effective products that meet or exceed customer and regulatory requirements.
Essential Duties and Responsibilities
- Lead the implementation, maintenance, and improvement of the QMS in compliance with cGMPs, ISO 13485:2016, ISO 14971:2019, and FDA 21 CFR:
Part 11 (Electronic Records; Electronic Signatures),
Part 820 (QSR)
Parts 361/1271 (Human Cells, Tissues, and Cellular and Tissue-Based Products)
And the relevant FDA Guidance documents for these regulations
- Provide oversight of product release strategy and ensure compliance through delegated authority.
- Establish and oversee policies for raw material acceptance, supplier controls, and product disposition.
- Ensure organizational compliance with labeling and packaging requirements through policy, audit, and review.
- Plan, manage, and resource internal audits, supplier audits, and regulatory inspections; serve as the host and primary point of contact for regulatory and notified body representatives.
- Assure programs related to document control, GMP training program, and controlled record management are in compliance.
- Direct Quality approval for the CAPA process, including nonconformance handling, root cause analysis, corrective/preventive action planning, and effectiveness verification.
- Provide oversight and guidance for product risk management in accordance with ISO 14971. Perform the quality review function for device pFMEA/dFMEAs and design control through delegation to appropriately trained and qualified staff.
- Review and approve quality-related documentation, including validation protocols, verification reports, design control deliverables, and batch records.
- Develop the key quality metrics for the periodic QMSR (Quality Management Systems Review) to drive systemic improvements, enhancing compliance and operational effectiveness.
- Develop, mentor, and direct the Quality team and oversee staff development across multiple quality functions to ensure alignment with company goals and regulatory expectations.
- Partner with cross-functional teams (Process Engineering, Manufacturing, Warehouse/Distribution, Regulatory Affairs, Operations, Sales) to support quality throughout the product lifecycle.
- Competency and proficiency in making standard Regulatory submissions, updates, and communications, such as FDA Establishment Registrations, 510k’s, State Registrations, and FSCA for Medical Devices.
- Ability to guide the organization to compliantly launch new medical device products and configurations to market
Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Quality, or related field; advanced degree strongly preferred.
- Minimum of 10–12 years of progressive experience in tissue processing quality assurance, with at least 5+ years in a director-level or equivalent leadership capacity.
- Comprehensive knowledge of ISO 13485, FDA 21 CFR Part 820, ISO 14971, and EU MDR.
- Demonstrated experience and favorable outcomes with FDA inspections, notified body audits, and supplier quality programs.
- Expertise in QMS software platforms and document control systems.
- Strong analytical, problem-solving, and decision-making skills.
- Professional certifications CQA, CQE, LSSBB, or RAC.
Competencies
- Executive leadership and organizational management skills
- Regulatory compliance expertise
- Effective communication and presentation abilities, including executive reporting and Board-level communication
- Strong attention to detail
- Continuous improvement mindset
- Demonstrated ability to mentor and coach staff and peers
Work Environment & Physical Requirements
- This position operates in a professional office and/or manufacturing environment.
- Regular use of computers, phones, and office equipment.
- May require occasional lifting of materials up to 25 pounds.
- Exposure to manufacturing floor environments.
Travel Requirements
- Occasional domestic travel may be required (estimated 20%) to support audits, supplier evaluations, and regulatory inspections.
Compensation & Benefits
- Competitive base salary commensurate with experience.
- Performance-based annual bonus eligibility.
- Comprehensive benefits package, including medical, dental, vision, life insurance, and 401(k) with company match.
- Paid time off, sick leave, and company holidays.
- Professional development opportunities and continuing education support.
Quality Supervisor / Quality Lead / Lead Quality Engineer required to oversee the quality assurance activities at a leading Rotating Equipment manufacturer and solutions provider based in Houston.
Quality Supervisor / Quality Lead / Lead Quality Engineer will be responsible for managing and overseeing inspection and testing processes to ensure that all activities align with company standards, customer requirements, and relevant industry codes. This role will directly support the resolution of quality issues and work towards continuous improvement on the production floor.
Quality Supervisor / Quality Lead / Lead Quality Engineer will work closely with operations, engineering, and project management teams to meet quality objectives, drive improvements, and maintain ISO 9001 certification.
Quality Supervisor / Quality Lead / Lead Quality Engineer Package
Circa $110,000
PTO
401K
Quality Supervisor / Quality Lead / Lead Quality Engineer Responsibilities
- Lead and coordinate the activities of a quality team to ensure accuracy and consistency in all inspection and testing activities.
- Supervise the inspection of rotating equipment components (compressors, turbines, steam actuators) to ensure dimensional, metallurgical, and non-destructive testing compliance.
- Review and approve non-conformance reports, ensuring all documentation is accurate, dispositions are appropriate, and timely closure is achieved.
- Coach, mentor, and develop team members to elevate technical proficiency and prepare them for higher levels of responsibility.
- Support root cause analysis and corrective/preventive action processes to ensure quality improvements.
- Ensure that all inspection equipment is calibrated and that NDT inspector certifications are up to date.
- Collaborate with operations and engineering teams to resolve any quality issues affecting production.
- Assist in customer and third-party audits, ensuring inspection documentation is prepared and available.
- Track inspection performance, identify trends in defects, and report key metrics to management.
- Ensure compliance with the company’s QMS (ISO 9001) and relevant industry codes (API, ASME, AWS).
Quality Supervisor / Quality Lead / Lead Quality Engineer Requirements
- 5+ years of experience in quality assurance or inspection within a manufacturing or service environment.
- 2+ years of supervisory experience, with a strong ability to lead without direct authority.
- Expertise in rotating equipment, including the inspection, assembly, and repair of compressors, turbines, and related components.
- Proficiency with dimensional inspection tools, NDT methods (MT, PT, UT, RT preferred), and welding processes.
- Familiarity with machining practices and processes.
- Knowledge of welding inspection and applicable codes (ASME, AWS) is advantageous.
Relevant professional certifications in quality or health & safety preferred.
- Ability to adapt to changing operational schedules and priorities, working across multiple sites as needed.
- Authorized to work in the United States and able to pass pre-employment drug, alcohol tests, and background checks.
Job Summary: CS Sunshine Holdings is seeking a Lean & 6 Sigma Manager to lead continuous improvement initiatives across our US manufacturing sites. This role will introduce the fundamental concepts and key tools of Lean and Six Sigma to newly established operations and drive cost reduction initiatives at the plant level. The Lean Manager will also support the development and implementation of the U.S. manufacturing operating system.
Responsibilities include:
- Provide training on Lean and Six Sigma concepts, methodologies, and tools to manufacturing teams.
- Collaborate with consultants from the Suzhou team to leverage the existing Lean framework and develop a Lean system tailored to U.S. manufacturing operations.
- Lead and facilitate Lean improvement activities across multiple manufacturing sites.
- Establish incentive and recognition programs for continuous improvement and cost reduction initiatives.
- Organize cross-site and cross-functional evaluations and benchmarking for improvement projects.
- Support plant teams in tracking and sustaining cost reduction initiatives and continuous improvement efforts.
- Assist manufacturing sites in achieving key operational KPIs.
- Prepare regular improvement reports and present progress, insights, and results to senior management.
- All other duties as assigned
Qualifications:
- Bachelor’s degree or above in Industrial Engineering, Engineering, or a related field.
- 10+ years of experience in the manufacturing industry.
- At least 2 years of experience in a similar role such as IE Manager or Lean Manager.
- Proven track record of successfully implementing at least two Lean or Six Sigma projects in large manufacturing or logistics organizations.
- Strong cross-functional collaboration skills with the ability to organize and lead teams across departments.
- Proficient in using software tools to process and analyze complex data.
- Strong capability in summarizing project outcomes, preparing reports, and delivering presentations.
- Comfortable collaborating with teams in Asia and working in a multicultural environment.
Physical Requirements and Working Conditions
- Ability to sit for extended periods while working at a computer
- Frequent use of hands and fingers for typing, filing, and operating office equipment
- Occasional standing, walking, bending, and reaching
- Ability to lift and carry light office materials (up to 10–15 lbs), such as files or office supplies
- Visual acuity to read screens, documents, and reports
Ability to attend meetings and interact with employees, clients, and vendors
Job Description:
Principal Azure Engineer, Platform & Delivery:
The Principal Azure Engineer, Platform & Delivery is a senior technical leader responsible for designing, building, and delivering enterprise-scale Microsoft Azure solutions. This role combines deep hands-on Azure engineering expertise with ownership of delivery outcomes, often serving as the technical lead for initiatives without dedicated project management. The ideal candidate can translate complex or ambiguous business needs into secure, scalable Azure solutions and ensure they are executed predictably and effectively.
Required Qualifications:
- Deep technical experience designing and operating high-availability, scalable infrastructure including networking, storage, virtualization, and identity.
- Developing and maintaining automated deployment modules using tools like Terraform or ARM templates.
- Optimizing delivery pipelines (e.g., Azure DevOps, GitHub Actions) to ensure repeatable, secure platform services.
- Proven experience implementing enterprise Azure networking architectures.
- Experience migrating and modernizing workloads from on-premises environments to Azure.
- Implementing governance frameworks, RBAC, and security baselines using Microsoft Defender for Cloud and Azure Policy.
- Demonstrated ability to lead engineers and influence stakeholders without formal authority.
- Experience defining and implementing monitoring and observability solutions.
- Lead end-to-end delivery of multiple concurrent Azure initiatives from intake and design through implementation and operational handoff.
- Act as the technical project lead for Azure initiatives where no formal project manager is assigned.
- Maintain visibility into all in-flight Azure work and provide regular status updates, risk reporting, and summaries.
- Coordinate work across infrastructure, security, networking, application, and vendor teams.
- Proactively identify delivery risks and blockers and drive resolution to keep initiatives moving forward.
- Balance speed, cost, risk, and compliance when making technical and delivery tradeoff decisions.
- Mentor and guide engineers, establishing technical standards, patterns, and best practices.
- Produce high-quality technical documentation, architectural artifacts, and operational runbooks.
- Foster strong partnerships with application teams to enable successful Azure adoption.
Additional Skills and Experience:
- Deep proficiency in Azure compute (VMs, AKS), storage, networking (VNETs, NSGs), and identity (Microsoft Entra ID).
- Experience operating in regulated environments such as healthcare, financial services, or higher education, including frameworks like HIPAA, HITRUST, SOC 2, or GDPR.
- Working knowledge of IT service management concepts.
- Experience with Azure Cost Management and FinOps practices.
- Strong problem investigation, root cause analysis, and decision-making skills.
Education and Experience:
- Bachelor’s degree or equivalent experience.
- Minimum of 10 years of professional IT experience, with at least 5 years in a senior, architect-level, or principal cloud engineering role.
- Demonstrated experience leading enterprise-scale Azure initiatives with multiple parallel workstreams.
Responsibilities:
- Supports the development of new products by applying engineering fundamentals and concepts to advance product development deliverables within the functional area.
- Support installation and qualification of R&D equipment.
- Perform data analysis and write technical reports based on product development activities.
- Support purchasing process of materials, equipment and testing consumables.
- Develop and validate test methods for raw materials and in-process inspections (i.e., Gage R&R).
- Ensure compliance with Design Control process requirements throughout the product lifecycle.
- Support Design Control process activities such as the creation and maintenance of Design History Files (DHF) and risk management (DFMEA) documentation.
- Support the development of DMR documentation such as raw material specifications, component specifications, test methods, manufacturing instructions, etc.
- Conduct engineering testing, including performance, reliability, and usability assessments.
- Participate in design reviews, root cause analysis, and failure investigations.
- Assist in technology transfer and process validation activities for new product introductions.
Second in Command - Challenger 300/350
Full-Time – Rapid City, SD
Jet Linx is seeking qualified Second in Command candidates for our Super Midsize jet aircraft for Part 91 and 135 flight operations. It is expected that the candidate lives, or be willing to relocate, within a 2-hour call out time of the aircraft.
Position Summary
The Second in Command (SIC) reports directly to the Base Chief Pilot. The SIC prepares and ensures the safe and efficient operation of company aircraft in accordance with the Federal Aviation Regulations and company procedures.
Minimum Requirements:
- Total Time - 1500 hours
- Total PIC - 500 hours
- Total Multi-Engine - 500 hours
- Total Turbine - 100 hours
- Total Instrument - 150 hours
Essential Functions:
- Manage duty, flight, and rest times to requirements of both the company and CFRs
- Maintain communication with the company for standby duty assignments, trip notifications, position calls, and pre- and post-flight reports
- Maintain and manage electronic flight bag (EFB) hardware and applications
- Ensure navigation charts, publications, and company manuals are current
- Maintain a current 1st Class medical certificate
- Convey strong, proactive decision-making skills
- Demonstrate Jet Linx’s core values in all interactions
Other Requirements:
- Initial or Recurrent 142 training in type within the last 24 months is preferred.
- Ability to obtain a U.S. driver's license
- Proof of eligibility to work in the US
- Current passport
- ATP (Unrestricted)
- 1st Class Medical
- FCC Restricted Radio License
- Ability to pass a pre-employment drug screen and submit to random drug/alcohol testing when required
- Unrestricted ability to travel to all EU, Canada, and Caribbean countries
- Ability to release and pass a FAA Pilot Record Database review with a System Chief Pilot
- Ability to work nights, weekends, and holidays
- Bachelor’s degree or equivalent work experience required
- Majority of work is completed in and around aircraft and aircraft terminals
- Move up to 50 pounds on a frequent basis
Compensation:
Jet Linx offers a competitive compensation and benefits package to team members. Starting base annual salary for this position ranges from $124,000 to $160,000. Actual base salary provided is dependent upon geographic location, aircraft size (crew positions), relevant education, training and experience of the candidate. Our comprehensive benefits package includes health, dental and vision insurance, 401(k) with 6% company match, paid time off and company paid life and short-term disability coverage.
Day to day:
The Job captain will be responsible for various projects that are in different phases of the production work flow and need to be completed by meeting project schedules, budget and quality standards. Will be managing the projects related to the permit sets, construction documents, master set construction documents, maintenance/creation and filling permit orders. Will be collaborating with counterparts in other groups such as Design and Engineering. Must be comfortable with a quick turn around time and able to manage the high volume. This role will NOT include designing
- Collaborate regularly with Design, Engineering, and other cross‑functional partners
- Manage multiple project teams and external consultants
- Support design initiatives, new options, styles, and architectural details
- Assist Architectural Operations with technology discovery and design efforts
- Deliver multiple projects simultaneously while meeting schedule, budget, and quality standards
- Manage construction documents, lot specifics, and revisions
- Interpret construction codes and project requirements
About the Role
We are seeking a detail-oriented and proactive Construction Project Engineer to support the successful planning, coordination, and execution of construction projects. This role works closely with the Project Manager and Superintendent to ensure projects are delivered on time, within budget, and in accordance with quality and safety standards.
Key Responsibilities
- Assist in managing day-to-day project operations from preconstruction through closeout.
- Coordinate subcontractors, vendors, and field teams to ensure timely completion of work.
- Review and process RFIs, submittals, shop drawings, and change orders.
- Maintain accurate project documentation, schedules, and cost tracking.
- Support budgeting, forecasting, and procurement activities.
- Monitor compliance with safety regulations, building codes, and quality standards.
- Participate in project meetings and provide progress updates to stakeholders.
- Assist with project closeout procedures, including punch lists and final documentation.
Qualifications
- Bachelor’s degree in Construction Management, Civil Engineering, or related field preferred.
- 1–2 years of construction project experience (internship experience considered).
- Knowledge of construction processes, materials, and methods.
- Familiarity with construction management software (e.g., Procore, Bluebeam, Primavera, MS Project).
- Strong analytical, organizational, and communication skills.
Preferred Skills
- Ability to read and interpret construction drawings and specifications.
- Strong problem-solving and decision-making abilities.
- Experience with cost control and scheduling.
- OSHA certification (preferred).
What We Offer
- Competitive salary and benefits
- Career growth and advancement opportunities
- Hands-on project experience
- Collaborative team environment
About Us
Clayco is a full-service, turnkey real estate development, master planning, architecture, engineering, and construction firm that safely delivers clients across North America the highest quality solutions on time, on budget, and above and beyond expectations. With $7.6 billion in revenue for 2024, Clayco specializes in the "art and science of building," providing fast track, efficient solutions for industrial, commercial, institutional, and residential related building projects.
The Role We Want You For
As a Project Director, you will be based on the construction project site and provide leadership on projects as the "single point of contact" for the owner, design department, and the project staff. Ensure quality and timely execution of design-build projects from design to completion and deliver the best solutions on projects valued anywhere from a $60 million to over $250 million. At Clayco, The Project Director will work with marketing, pre-construction services, business unit leaders, and mentoring Project Managers and Engineers and have overall responsibility for these projects.
The Specifics of the Role
- Build client and subcontractor relationships.
- Team with Architects, Engineers, and Planners to create and manage a design schedule.
- Establish project forecasts and budgets.
- Manage costs.
- Accept full responsibility for project execution.
- Mentor and develop project management staff.
Requirements
- Bachelor’s Degree in Construction Management, Engineering, Architecture or related.
- 15-20 years of experience managing construction projects ($100+ million) ideally design-build.
- Demonstrated knowledge of construction principles, practices, and technology.
- Previous experience leading a successful project management team.
- Ability to walk a job site, climb ladders, and scale multi-floor scaffolding.
- Ability to lift objects of at least 50 lbs.
Some Things You Should Know
- Our clients and projects are nationwide – Travel will be required.
- No other builder can offer the collaborative design-build approach that Clayco does.
- We work on creative, complex, award-winning, high-profile jobs.
- The pace is fast!
- This position is classified as a safety-sensitive role in accordance with applicable state and federal laws. Candidates selected for this position will be subject to a comprehensive background check, which includes mandatory drug testing.
Why Clayco?
- 2025 Best Places to Work – St. Louis Business Journal, Los Angeles Business Journal, and Phoenix Business Journal.
- 2025 ENR Midwest – Midwest Contractor (#1).
- 2025 ENR Top 100 Design-Build Firms – Design-Build Contractor (Top 5).
- 2025 ENR Top 100 Green Contractors – Green Contractor (Top 3).
- 2025 ENR Top 25 Data Center Builders – Data Center Contractor (Top 3).
Benefits
- Discretionary Annual Bonus: Subject to company and individual performance.
- Comprehensive Benefits Package Including: Medical, dental and vision plans, 401k, generous PTO and paid company holidays, employee assistance program, flexible spending accounts, life insurance, disability coverage, learning & development programs and more!
Compensation
- The salary range for this position considers a wide range of factors in making compensation decisions including but not limited to: Education, qualifications, skills, training, experience, certifications, internal equity, and location. Compensation decisions are dependent on the facts and circumstances of each case.
Suffolk is a national enterprise that builds, innovates, and invests. We provide value across the entire project lifecycle through our core construction management services and complementary business lines in real estate investment, design, self-perform construction, and technology start-up investment (Suffolk Technologies). By integrating data, artificial intelligence, and advanced technology through our Seamless Platform, we connect design, construction, and operations to deliver smarter, more predictable results and redefine how America builds.
Suffolk – America’s Contractor – is a national company with more than $8 billion in annual revenue, 3,000 employees, and 17 offices, including Boston (headquarters), New York City, Miami, West Palm Beach, Tampa, Estero, Dallas, Los Angeles, San Francisco, San Diego, Las Vegas, Herndon, U.S. Virgin Islands, and other key markets. Suffolk manages some of the most complex and transformative projects in the country, serving clients across healthcare, life sciences, education, gaming, aviation, transportation, government, mission critical, and commercial sectors. Suffolk is privately held and is led by founder, chairman and CEO John Fish. Suffolk is ranked #8 on ENR’s list of “Top CM-at-Risk Contractors.” For more information, visit and follow Suffolk on Facebook, Twitter, LinkedIn, YouTube, and Instagram.
The Role:
The Senior MEP Project Manager is responsible for managing, field inspections, problem solving, and coordinating all necessary Mechanical, Electrical, Plumbing and Fire Protection project resources and documentation throughout the entire project lifecycle. This includes the selection and management of MEP subcontractors, and the review, management, and administration of mechanical bid tabs/Exhibit Bs, MEP submittals, monthly MEP requisitions and change orders, and MEP contractor schedule/performance.
Responsibilities:
- Responsible for review of mechanical bid tabs as well as exhibit B in contract
- Responsible for interviewing and selecting sub-contractors for each project
- Responsible for day-to-day management of MEP sub-contractors
- Responsible for reviewing and approval of MEP monthly requisitions
- Responsible for reviewing and approval of MEP change orders
- Responsible for site walks to ensure work is progressing according to schedule, including schedule updates
- Responsible for direct communication with BIM/VDC personal and Superintendent to ensure coordination is on track with schedule
- Work with A/E team to develop successful solutions to coordination items
- Responsible for the review all MEP submittals
- Responsible for obtaining all documentation from inspections and testing (varies on size of job)
- Responsible for overseeing the MEP & FP contractor as well as the Commissioning agent
- Responsible for coordinating and working with any Owner third party MEP contractors or testing agencies
- Responsible for obtaining all mechanical close out documentation; as builts, attic stock and O&Ms
- Coordinate multi trade portions of the project; example - curtain wall with security, electrical and door hardware
- Develop and monitor equipment delivery logs, organize submittal process for long lead items first
- Attend weekly owner meetings, subcontractor meetings, coordination meeting and field meetings
- Obtain approval/sign off from any and all AHJs
- Work with retail and/or tenant fit out where applicable
- Develop work lists, and complete MEP punch list
- Coordinate owner training and turnover
- Work with all public utility companies to ensure project requirements are met. Including temporary electrical, steam, and natural gas
- Coordinate and direct as needed all parties to successfully complete life safety inspections
- Coordinate between trades and documents; electrical requirements for mechanical are correct. Light power match electrical drawings etc.
Qualifications:
- Bachelor of Science (technical/engineering degree) Mechanical, HVAC, Plumbing, Electrical and Fire protection
- Minimum 10+ years experience with Mechanical, Electrical, Plumbing and Fire Protection Systems
- Minimum of 5+ years of project management experience
- Strong computer skills are required i.e. MS Excel, Word, Outlook
- Ability to read and comprehend drawings and specifications
- Complete understanding of BIM/VDC coordination including various hit detection programs
- Knowledge of Local, City, State, and International building codes for the location of the project
- Knowledge of ASHRAE, NEC, NFPA, and LEED requirements
- Extensive knowledge of testing and balancing and commissioning practices
- Ability to make decisions quickly and accurately
- Ability to communicate at all levels
- Candidate must possess Suffolk’s Core Values: Passion, Integrity, Hard Work, Professionalism, and Caring
While performing the duties of this job, the employee is regularly required to sit for long periods of time; talk or hear; perform fine motor, hand and finger skills in the use of a keyboard, telephone, or writing. The employee is frequently required to stands; walk; and reach with arms and/or hands. Specific vision abilities include close vision, distance vision, depth perception and the ability to adjust focus. The employee will spend their time in an office environment with a quiet to moderate noise level. Job site walking.
Suffolk provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, pregnancy or maternity, national origin, citizenship, genetic information, disability, protected veteran, gender identity, age or any other status protected by law. This policy applies to recruiting, hiring, transfers, promotions, terminations, compensation, benefits, and all other terms and conditions of employment. Suffolk will not tolerate any unlawful discrimination toward, or harassment of, applicants or employees by anyone at Suffolk, or anyone working on behalf of Suffolk.