обновлено 8 дней назад
Senior Supplier Quality Engineer (Life Sciences)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Supplier Quality Engineer (Life Sciences): Ensuring suppliers meet quality, regulatory, and technical requirements through qualification, audits, issue resolution, and performance management with an accent on supplier risk, compliance, and continuous improvement. Focus on leading SCARs and nonconformance investigations, evaluating supplier changes, and coordinating cross-functional quality and regulatory activities.
Location: Marlborough, MA, United States
Company
develops and manufactures products for the life sciences and biopharmaceutical industries.
What you will do
- Qualify new and existing suppliers by evaluating manufacturing processes, capabilities, quality systems, and compliance.
- Plan and conduct supplier audits, document findings, assess risks, and follow up on corrective actions.
- Lead supplier nonconformance investigations and SCARs, including root cause analysis and effectiveness verification.
- Evaluate supplier change notifications and coordinate quality, regulatory, and cross-functional actions.
- Monitor supplier performance through scorecards, NCMRs, SCARs, audits, and other quality indicators.
- Support supplier risk assessments, development plans, validation, and continuous improvement initiatives.
Requirements
- Bachelor’s degree in Engineering, Quality, Life Sciences, or a related technical discipline, or equivalent relevant experience.
- 7+ years of experience in Supplier Quality, Quality Engineering, Manufacturing Quality, or a related field.
- Experience with supplier qualification, supplier audits, nonconformance investigations, CAPA/SCAR, and root cause analysis.
- Working knowledge of quality management systems and applicable regulatory requirements, including GMP and FDA requirements.
- Ability to evaluate manufacturing processes, technical documentation, and supplier quality systems.
- Ability to travel to supplier locations as required.
Nice to have
- Experience in life sciences, biopharmaceutical manufacturing, medical devices, or another regulated industry.
- ASQ, Lead Auditor, or similar quality certification.
- Experience with statistical methods, process capability, validation, or continuous improvement tools.
Culture & Benefits
- Full-time role collaborating with Quality, Sourcing, Engineering, Operations, and Regulatory teams.
- Regular travel to supplier locations may be required.
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