4 дня назад
Sr Supplier Quality Engineer (MedTech)
79 000 - 127 650$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Sr Supplier Quality Engineer (MedTech): Leading supplier quality assurance for contract manufacturing sites and raw material suppliers supporting medical device production, with an accent on supplier non-conformities, CAPA, audits, process validation, and regulatory compliance. Focus on managing supplier changes, investigations, quality agreements, performance metrics, and cross-functional remediation projects.
Location: Palm Beach Gardens, Florida, United States of America
Base pay: $79,000–$127,650 per year
Company
Johnson & Johnson MedTech develops less invasive and personalized medical treatments and solutions.
What you will do
- Lead supplier quality assurance for contract manufacturing sites and raw material suppliers supporting medical device production.
- Manage supplier non-conformities, SCARs, CAPAs, change requests, quality agreements, and supplier assessments.
- Support supplier process validations, product validations, first article inspections, control plans, capability studies, and PLM changes.
- Contribute to product and process investigations, supplier audits, regulatory inspections, and supplier transfer projects.
- Report supplier performance metrics and participate in quality projects involving legacy review, remediation, integration, and standards improvement.
- Collaborate with Quality, Engineering, R&D, Regulatory, Sourcing, suppliers, and government or notified-body agencies.
Requirements
- Bachelor’s degree or equivalent in Engineering, Life Science, or a related field.
- 2–4 years of experience in a GMP- and/or ISO-regulated industry.
- Strong communication, teamwork, problem-solving, analytical reasoning, and root cause analysis skills.
- Ability to work effectively in a fast-paced environment and collaborate across functions.
- Fluent written and spoken English required.
- Up to 10% travel may be required.
Nice to have
- Medical device or pharmaceutical industry experience.
- Knowledge of FDA and ISO regulations, including FDA CFR Part 820 and ISO 13485.
- Experience with machining, injection molding, robotics, electronics, software, operations supplier quality, or auditing.
- Six Sigma, Lean, or ASQ certification and professional licenses.
- Management or supervision experience.
Culture & Benefits
- Full-time employment with vacation, sick time, holidays, personal and family time, parental leave, bereavement leave, caregiver leave, volunteer leave, and military spouse time off.
- Eligibility to participate in the company’s long-term incentive program.
- Inclusive work environment focused on diversity, dignity, and equal opportunity.
- Work includes compliance with health, safety, environmental, and applicable federal, state, local, and company regulations.
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