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Senior Quality Engineer (MedTech)
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TL;DR
Senior Quality Engineer (MedTech): Leading quality assurance for medical-device manufacturing, packaging, labeling, and finished-goods control processes with an accent on GMP compliance, risk management, CAPA, and ISO standards. Focus on investigating non-conformances, conducting audits, implementing corrective actions, and improving quality and reliability systems across two manufacturing sites.
Location: Palm Beach Gardens and West Palm Beach, Florida, United States. Full-time onsite role split between two Palm Beach County manufacturing sites; less than 10% travel required.
Company
Johnson & Johnson MedTech develops surgical technologies, orthopedic solutions, interventional products, and enabling technologies through its DePuy Synthes organization.
What you will do
- Provide quality support for daily manufacturing, inspection, and testing activities.
- Lead the initiation, containment, investigation, disposition, and closure of non-conformances across the Palm Beach Gardens and West Palm Beach sites.
- Support CAPA records, including risk assessment, root-cause investigation, corrective and preventive actions, and effectiveness monitoring.
- Ensure manufacturing operations comply with GMP, ISO, EES, and other applicable quality standards.
- Address or escalate product and process complaints, monitor performance metrics, and support management reviews.
- Conduct quality-system audits and implement measurement systems and continuous-improvement initiatives.
Requirements
- Bachelor’s degree in engineering, life science, or a related field.
- 3–5 years of relevant work experience or internships.
- Experience in regulated industries and manufacturing or operations.
- In-depth knowledge of product and process risk management, including MDSAP, MDD, MDR, FDA, and ISO standards.
- Demonstrated experience implementing risk-mitigation measures.
- Ability to work onsite across two locations in Palm Beach County, Florida.
Nice to have
- Advanced knowledge of Six Sigma methodologies.
- Understanding of change-control and risk-management processes.
Culture & Benefits
- Inclusive work environment focused on diversity, dignity, and equal opportunity.
- Opportunity to support medical-device products and technologies intended to improve surgical care.
- Employment is expected to transition to DePuy Synthes following the planned separation of the orthopaedics business, subject to legal, regulatory, and customary approvals.
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