Supplier Quality Engineer
Supplier Quality Engineer
Posted on :
19-07-2025
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1 Vacancy
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Job Description
Job Description:
- The Senior Supplier Quality Engineer will support External Manufacturing and Supplier Quality functions by executing both strategic and tactical quality activities.
- This includes base business support nonconformance (NC) root cause investigations and driving quality improvements to ensure compliance reduce risk and enhance efficiency.
- The role involves strong collaboration with suppliers and cross-functional teams (Procurement Operations R&D Supply Chain and NPI) to minimize supply chain risks while implementing innovative measurable improvements.
- The ideal candidate will work with minimal supervision and bring deep knowledge of medical device regulations GMP and supplier quality systems.
Responsibilities:
- Provide sound risk-based QA direction and make timely decisions on complex quality and compliance issues.
- Conduct root cause analysis and failure investigations; approve and monitor supplier corrective actions.
- Ensure execution of Quality Management Systems (QMS) related to supplier selection change control qualification NC/CAPA quality agreements and performance monitoring.
- Lead risk assessment and mitigation strategies for suppliers including Quality Agreement creation and control plan assessments.
- Serve as a key liaison with suppliers ensuring strong relationships and compliance with regulatory and company requirements.
- Perform tasks in compliance with safety policies quality systems and cGMP requirements.
- Take on additional duties as assigned with flexibility and adaptability.
- External Manufacturing & Supplier Quality.
- Medical Device Regulatory Compliance (FDA ISOCFR Part 820).
Requirements:
- 4 6 years in a regulated medical device or life sciences manufacturing environment.
- Strong background in Supplier Quality Engineering.
- Hands-on production line experience including validation activities.
- Expertise in NC/CAPA FMEA Design Control and New Product Introduction (NPI).
- Prior experience with Johnson & Johnson or similar organizations is preferred.
- Critical thinking detail-oriented strong verbal and written communication skills.
- Demonstrated ability to lead projects within a regulated environment.
- Supervisory or team leadership experience; ability to drive timelines and project deliverables.
- Proficiency in Excel (chart creation scheduling tracking).
- Program or project management skillset.
Employment Type
Full-time
Key Skills
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