обновлено 9 дней назад
Senior Supplier Quality Engineer (Metals)
87 100 - 130 600$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Senior Supplier Quality Engineer (Metals) (Medical Devices): Managing and improving supplier quality for metal components used in medical devices with an accent on supplier governance, regulatory compliance, and metals manufacturing. Focus on leading audits, PPAP and process validation, resolving supplier nonconformities through SCAR, and improving supplier performance with data-driven metrics.
Location: Acton, Massachusetts, United States; on-site office, plant, or lab work required. Approximately 25% travel is expected.
Annual base salary: $87,100–$130,600, with potential incentive compensation.
Company
is a medical device company developing the Omnipod insulin management platform and other wearable drug-delivery technologies.
What you will do
- Manage supplier quality engineering deliverables for metal components, sourcing strategies, and continuity of production.
- Partner with suppliers, sub-tier suppliers, supply chain, engineering, operations, procurement, and regulatory teams to improve supplier performance.
- Develop and monitor KPIs, dashboards, risk-management strategies, and supplier quality-system metrics.
- Lead sustaining initiatives involving cost reduction, capacity increases, dual sourcing, and risk mitigation.
- Investigate supplier-related nonconformities, lead root-cause analysis, and drive corrective actions through Supplier Corrective Action Reports.
- Review supplier change requests and support supplier selection, audits, process qualification, and new-product quality activities.
Requirements
- Bachelor’s degree in Mechanical Engineering, Industrial Engineering, or a related field.
- 5–8 years of progressive experience in medical device supplier quality, quality, manufacturing, or engineering with a bachelor’s degree; 3 years with a master’s degree.
- Experience with metal stampings and spring forming, preferably including material selection, design for manufacturability, cosmetic criteria, and process qualification.
- Experience with PPAP, DOE, process capability analysis, Gage R&R, control plans, SPC, inspection procedures, and supplier performance improvement.
- Strong understanding of QMS, complaint handling, 21 CFR Part 820, and Part 11 requirements.
- Strong analytical, organizational, communication, problem-solving, and cross-functional collaboration skills.
Nice to have
- Additional experience with metals manufacturing or materials.
Culture & Benefits
- Collaborative, team-oriented, high-energy, and fast-paced working environment.
- Medical, dental, and vision insurance.
- 401(k) plan with company match.
- Paid time off and employee wellness programs.
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