Senior CAPA Engineer

Senior CAPA Engineer – Philips

Join the Philips team as a Senior CAPA Engineer. You will advise and critically review Corrective and Preventive Actions (CAPAs) and facilitate CAPA investigations from issue identification through implementation of solutions and effectiveness monitoring.

• Facilitate product and process CAPA investigations from issue identification through implementation of solutions and effectiveness monitoring.
• Update business processes related to CAPA.
• Perform timely, detailed CAPA engineering tasks such as assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis, and quality problem solving.
• Project manage all aspects of CAPA activity, including securing commitment of cross‑functional resources, scheduling CAPA team meetings, and ensuring deliverables per project timelines.
• Represent CAPAs during audits and CAPA Review Board meetings.
• Lead and mentor cross‑functional teams with appropriate root cause analysis techniques.
• Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non‑conformances.
• Work with all levels of management to ensure CAPA action plans can be supported and resources/costs are available.
• Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement.

• Minimum 5+ years’ experience in Quality Engineering within FDA‑regulated medical device environments, with proven expertise in CAPAs, including facilitating CAPA investigations from issue identification through implementation and effectiveness monitoring.
• Experience representing CAPAs during audits and CAPA Review Board meetings.
• Experience in non‑conformance, root cause analysis and data/trend analysis.
• Detailed knowledge of global medical device regulations, requirements and standards, including 21 CFR Parts 803, 806, 820; ISO 13485, ISO 14971; EU Medical Device Directive (93/42/EEC); EU Medical Device Regulation;
  Canadian Medical Devices Regulation (SOR/98‑282); etc.
• Bachelor’s Degree in Quality, Engineering or related field.
• Ability to perform required physical, cognitive and environmental job requirements with or without accommodation.

We believe that we are better together than apart. For our office-based teams, this means working in person at least three days per week. This is an office role located at our Orlando, FL facility.

We are a health technology company built on the belief that every human matters. Our goal is to provide high‑quality healthcare to all people everywhere.

Pay range for this position in Orlando, FL is $87,000 to $139,200 (actual base pay may vary within this range depending on multiple factors).

• US work authorization is required; no sponsorship will be considered.
• No relocation benefits are provided; candidates must reside in or near Orlando, FL.
• Travel up to 10% may be required.

Senior CAPA Engineer – Senior level, Full‑time.

Philips is an Equal Employment and Opportunity Employer, including Disability and Veterans, and maintains a drug‑free workplace.