Staff Supplier Quality Engineer
Position Summary:
The Staff Supplier Quality Engineer (SSQE) is a senior-level technical expert responsible for ensuring that all externally sourced materials, components, and services meet the company's quality standards and regulatory requirements. This role leads complex supplier quality initiatives, supports new product development, and drives continuous improvement across the supply base in alignment with FDA, ISO 13485, and other applicable standards.
Key Responsibilities:
- Lead supplier qualification, onboarding, and periodic re-evaluation activities, including audits and risk assessments.
- Serve as the technical liaison between suppliers and internal cross-functional teams (R&D, Manufacturing, Regulatory, etc.).
- Support design transfer and validation activities (IQ/OQ/PQ) by ensuring supplier readiness and compliance.
- Investigate and resolve supplier-related non-conformances using structured problem-solving tools (e.g., 8D, DMAIC).
- Drive supplier corrective and preventive actions (SCARs) and monitor effectiveness.
- Develop and maintain supplier quality metrics and dashboards; present findings to leadership.
- Collaborate with Procurement to develop supplier quality agreements and ensure alignment with regulatory expectations.
- Participate in regulatory inspections and internal audits as the subject matter expert for supplier quality.
- Mentor junior engineers and support the development of supplier quality engineering best practices.
Qualifications:
- Bachelor's degree in Engineering, Life Sciences, or related field (Master's or advanced certifications preferred).
- 7+ years of experience in supplier quality or quality engineering in the medical device or regulated industry.
- Deep understanding of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and applicable global regulations.
- Proven experience with supplier audits, validation protocols, and risk management tools (e.g., PFMEA, DFMEA).
- Strong analytical and communication skills; ability to influence cross-functional teams and suppliers.
- Proficiency in quality systems and tools (e.g., QMS, ERP, Minitab, TrackWise).
- ASQ CQE, CQA, or Six Sigma certification is a plus.
Preferred Skills:
- Experience with Class II or Class III medical devices.
- Familiarity with electronic components, injection molding, or precision machining suppliers.
- Ability to travel up to 25% for supplier audits and support.
FAQs
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