обновлено 23 часа назад
Supplier Quality Engineer
80 000 - 105 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Supplier Quality Engineer (Biotech): Managing supplier qualification, audits, quality investigations, and performance improvement for a global supplier base with an accent on regulatory compliance, risk mitigation, and supplier accountability. Focus on evaluating manufacturing processes, leading SCAR and root-cause activities, assessing supplier changes, and coordinating quality improvements across Engineering, Operations, Sourcing, and Regulatory teams.
Location: Waltham, MA or Hopkinton, MA, United States; travel to supplier locations as required.
Salary: $80,000–$105,000 annually, plus eligibility for variable cash programs and, for eligible roles, equity.
Company
develops technologies and solutions for bioprocessing and the production of biologic drugs.
What you will do
- Evaluate and qualify new and existing suppliers, including 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.
- Assess supplier change notifications and coordinate quality and regulatory impact reviews.
- Monitor supplier performance through scorecards, NCMRs, SCARs, audits, and other quality indicators.
- Collaborate with Quality, Sourcing, Engineering, Operations, and Regulatory teams on validations, supplier changes, and quality improvements.
Requirements
- Bachelor’s degree in Engineering, Quality, Life Sciences, or a related technical discipline, or equivalent experience.
- At least 2 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 GMP and FDA requirements.
- Ability to evaluate manufacturing processes, technical documentation, and supplier quality systems.
- Strong problem-solving, analytical, communication, and cross-functional collaboration skills.
Culture & Benefits
- Cross-functional and collaborative work with Quality, Sourcing, Engineering, Operations, and Regulatory professionals.
- Paid time off.
- Health, dental, and vision benefits.
- Retirement benefits and flexible spending accounts.
- Eligibility for variable cash programs and equity for eligible roles.
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