Staff Supplier Quality Engineer- Contract Manufacturing

We need to output HTML fragment with sections: About the role, Responsibilities, Qualifications, Skills, Benefits, Pay, Schedule? We need to include only sections that have real specific content. The posting includes "About The Role" (we already have overview but we need to include About the role heading? The instruction: use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Do NOT repeat the job title as a heading (the page already shows it) and do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short

or drop it. We have sections: Overview (maybe not needed as heading? Could be considered "About the role"? Actually there is "Overview" then "Who We Are" then "About The Role". The instruction says use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we should create headings for those sections if they have content. We have "About The Role" content: a paragraph describing role. That's suitable for About the role. We have "Responsibilities" with a big list under "WHAT YOU'LL DO:" and bullet points (though not bullet formatted but sentences). We need to convert to

• for any list of duties/requirements/benefits. So we need to extract each duty as list items. We have "Qualifications" with subheadings Education, Experience, Skills/Competencies Required. The instruction says use

  for section headings like Qualifications, Skills, Benefits, Pay, Schedule. So we could have Qualifications heading, then inside maybe subheadings? But we should not create extra headings beyond those listed unless they have real content. Could we treat Education, Experience, Skills/Competencies as sub-sections under Qualifications? Probably we can keep them as

  or

  . The instruction: Use
  • for any list of duties/requirements/benefits, and

    for prose. So for qualifications we can have a

    summarizing? But we need to preserve all substantive information; we cannot summarize away detail. So we need to list each qualification item. Could use

    for each category. Similarly Skills/Competencies Required is a list; we could treat as Skills section. We have "What We Offer" includes compensation package details: Base Salary, bonus, equity, health insurance, HSAs, PTO, 401(k), wellness, recognition, commuter benefits. That's Benefits and Pay. So we need Pay section (Base Salary, bonus, equity) and Benefits section (health, dental, vision, HSAs/FSAs, PTO, 401(k), wellness, recognition, commuter benefits). Also maybe Schedule? Not mentioned. So we should not create Schedule section. We also have "Our Commitment To Equal Opportunity And Veteran Inclusion" which is boilerplate EEO; we should remove. We need to remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. There's no explicit application instructions but we should drop the EEO statement. We need to preserve all substantive information. Thus final HTML:

    About the role

    ... paragraph from About The Role ...

    Responsibilities

    • Lead the quality workstream for contract manufacturer qualification, onboarding, governance, and ongoing oversight, ensuring controls are appropriate for product, process, patient, compliance, and continuity-of-supply risk while supporting consistent quality performance and reliable product availability.
    • Provide technical quality leadership for product, process, equipment, tooling, test method, facility, and manufacturing-site transfers to contract manufacturers, including transfer planning, readiness assessments, risk reviews, execution, and post-transfer stabilization, ensuring seamless collaboration and successful implementation across internal and external stakeholders.
    • Partner with R&D and Design Assurance during development and design changes to ensure supplier capability, manufacturability, critical requirements, risk controls, verification needs, and transfer requirements are defined early and translated into effective and sustainable supplier controls.
    • Establish and maintain the contract manufacturer quality oversight model, including quality plans, quality agreements, responsibility matrices, escalation pathways, performance reviews, and governance routines that encourage accountability, transparency, and strong cross-functional partnerships.
    • Lead risk-based process validation and transfer strategies, including IQ/OQ/PQ or PPQ, validation master planning, protocol and report review, statistical rationale, acceptance criteria, and maintenance of the validated state to ensure product quality, process reliability, and regulatory compliance.
    • Assess and approve complex contract manufacturer and supplier changes, deviations, concessions, and implementation plans, ensuring technical, quality-system, risk-management, and regulatory impacts are identified, evaluated, and addressed prior to execution.
    • Define and implement risk-based receiving, in-process, release, traceability, monitoring, and supplier-evidence controls, with clear linkage to specifications, drawings, critical-to-quality characteristics, process risks, and product risk-management documentation to support product integrity and patient safety.
    • Lead technical problem solving for significant supplier and contract manufacturer nonconformances, investigations, CAPAs, and SCARs using data-driven root cause analysis, effective containment, sustainable corrective actions, and effectiveness verification to prevent recurrence and drive continuous improvement.
    • Provide engineering leadership for supplier process capability, measurement-system analysis, test-method validation, inspection strategy, control plans, sampling, SPC, and ongoing process-performance monitoring, leveraging technical expertise and data insights to enhance quality and operational performance.
    • Lead contract manufacturer quality readiness for product launches, capacity expansion, new equipment, line moves, automation, and major process changes, including the definition and closure of quality deliverables and readiness gaps to ensure successful execution and business continuity.
    • Partner with Supplier Quality team members to standardize contract manufacturer controls, strengthen technical capability, provide guidance on complex engineering challenges, and ensure consistent execution across suppliers while fostering collaboration and knowledge sharing.
    • Lead or provide technical support for contract manufacturer audits, process assessments, technical reviews, business reviews, and supplier escalations; ensure remediation plans are risk-based, sustainable, and effectively implemented to strengthen long-term performance and compliance.
    • Develop, review, and approve high-quality technical and quality documentation, including transfer plans, validation strategies, quality plans, risk assessments, change assessments, engineering justifications, procedures, reports, and quality records that support clarity, traceability, and inspection readiness.
    • Apply strong project management practices to coordinate cross-functional workstreams, decisions, dependencies, risks, timelines, and deliverables across internal teams and external manufacturing partners, driving alignment, execution excellence, and achievement of shared objectives.
    • Identify systemic opportunities to enhance contract manufacturing governance, transfer execution, supplier controls, process capability, and prevention of recurring quality issues through innovation, continuous learning, and proactive improvement initiatives.
    • Perform other duties as assigned in support of organizational goals and the delivery of safe, effective, and high-quality products for patients.

    Qualifications

    Education: Bachelor’s degree in Engineering or a related technical discipline; Master’s degree preferred.

    Experience: Minimum of 10 years of progressive experience in Supplier Quality, Quality Engineering, Manufacturing Engineering, Process Engineering, Process Engineering, or a related role, including significant experience supporting contract manufacturers and manufacturing transfers. Demonstrated experience working within a medical device quality system and applicable requirements, including ISO 13485, FDA QMSR / 21 CFR Part 820, and risk management principles. Demonstrated experience leading complex, cross-functional product or manufacturing transfers, contract manufacturer qualification, process validation, and supplier change implementation. Demonstrated success influencing technical and business decisions across internal engineering teams and external manufacturing partners without direct authority.

    Skills

    • Deep technical knowledge of contract manufacturer lifecycle controls, supplier qualification, supplier development, quality agreements, performance governance, and risk-based oversight.
    • Demonstrated technical leadership in: Product and manufacturing transfer planning, readiness, execution, and stabilization
    • Process validation strategy (IQ/OQ/PQ/PPQ), process capability, statistical methods, sampling, SPC, and measurement systems
    • Design-change and supplier-change implementation, including technical, quality, risk-management, and regulatory impact assessment
    • Ability to interpret drawings, specifications, process documentation, validation evidence, risk-management files, and manufacturing data to define appropriate controls.
    • Advanced problem-solving capability, including complex investigations, root cause analysis, CAPA, SCAR, containment, and effectiveness verification.
    • Ability to establish practical controls and decision gates that protect product quality while enabling transfer, scale-up, and supply continuity.
    • Excellent technical writing, communication, facilitation, and executive-level presentation skills.
    • Strong cross-functional leadership and ability to build effective partnerships with R&D, Design Assurance, Manufacturing Engineering, Operations, Regulatory Affairs, Supply Chain, and external manufacturers.
    • Advanced project-management skills with the ability to lead multiple complex workstreams, manage ambiguity, and drive timely decisions and deliverables.
    • Experience leading supplier or contract manufacturer audits and technical process assessments.
    • Willingness to travel domestically and internationally for contract manufacturer transfers, qualification, audits, issue resolution, and governance activities.
    • Preferred Experience with sterile or implantable medical devices, external manufacturing networks, and global manufacturing transfers highly desired.
    • ASQ Certified Quality Engineer, Six Sigma certification, or ISO 13485 Lead Auditor certification is a strong plus; experience with QAD, MasterControl, or TrackWise is preferred.

    Pay

    • Base Salary of $135,000-$157,500/yr
    • 10% Discretionary bonus
    • Equity participation as approved by Board of Directors (4-year vesting schedule)

    Benefits

    • Comprehensive health, dental, and vision insurance plans
    • Flexible Health Savings Accounts (HSAs) and/or Flexible Spending Accounts (FSAs)
    • Generous paid time off (vacation, sick leave, holidays, and flexible time off that is available for Exempt employees)
    • 401(k) retirement plan with company match
    • Employee wellness initiatives, mental health resources, and Employee Assistance Program (EAP)
    • Employee recognition programs and awards
    • Commuter benefits or transportation stipends
    We should not include Schedule section. Check for any duplicated content: we have captured all. We need to ensure we didn't include any boilerplate like "Our Commitment To Equal Opportunity And Veteran Inclusion". We omitted. We need to ensure we didn't include any "Overview" or "Who We Are" sections. The instruction says use headings only for those specific ones; we can omit Overview and Who Are as they are not required headings. However we might want to include some of that content? The instruction says preserve ALL substantive information; do NOT invent or summarize away detail. If we omit the "Overview" and "Who We Are" paragraphs, we would be losing substantive information about the company. But the instruction says we should use headings for sections like About the role, Responsibilities, etc. It didn't forbid having other headings not in the list, but said "use

    for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." The "e.g." suggests those are examples, not exclusive list. However later: "IMPORTANT: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder