Senior CAPA Engineer
About The Position
The Senior CAPA Engineer will advise and critically review Corrective and Preventive Actions (CAPAs) and facilitate CAPA investigations from issue identification through implementation of solution and effectiveness monitoring. Your role: Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring Responsible for updating the business processes relating to CAPA Responsible for performing timely, detailed CAPA engineering tasks like assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis and quality problem solving Project manages all aspects of CAPA activity which includes gaining themitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines Represent CAPAs during audits and CAPA Review Board meetings Lead and mentor cross-functional teams with the implementation of appropriate root cause analysis techniques Analyze quality monitoring data sources and statistical techniques to identify existing and potential causes of non-conformances Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement You're the right fit if: You've acquired a minimum of 5+ years' experience in Quality Engineering within FDA regulated medical device environments, with proven expertise in Corrective and Preventive Actions (CAPAs) to include facilitating CAPA investigations from issue identification through implementation of solution and effectiveness monitoring. You have experience representing CAPAs during audits and CAPA Review Board meetings. You have experience in non-conformance, root cause analysis and data/trend. Analysis. You have detailed knowledge of appropriate global medical device regulations, requirements and standards including 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation, Canadian Medical Devices Regulation (SOR/98-282), etc. You have a Minimum of a Bachelor's Degree (Required) in Quality, Engineering or related fields. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without amodation for this position.
Requirements
- You've acquired a minimum of 5+ years' experience in Quality Engineering within FDA regulated medical device environments, with proven expertise in Corrective and Preventive Actions (CAPAs) to include facilitating CAPA investigations from issue identification through implementation of solution and effectiveness monitoring.
- You have experience representing CAPAs during audits and CAPA Review Board meetings.
- You have experience in non-conformance, root cause analysis and data/trend. Analysis.
- You have detailed knowledge of appropriate global medical device regulations, requirements and standards including 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation, Canadian Medical Devices Regulation (SOR/98-282), etc.
- You have a Minimum of a Bachelor's Degree (Required) in Quality, Engineering or related fields.
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without amodation for this position.
Responsibilities
- Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring
- Responsible for updating the business processes relating to CAPA
- Responsible for performing timely, detailed CAPA engineering tasks like assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis and quality problem solving
- Project manages all aspects of CAPA activity which includes gaining themitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines
- Represent CAPAs during audits and CAPA Review Board meetings
- Lead and mentor cross-functional teams with the implementation of appropriate root cause analysis techniques
- Analyze quality monitoring data sources and statistical techniques to identify existing and potential causes of non-conformances
- Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available
- Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement
Benefits
- Employees are eligible to participate in ourprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (withpany contribution), stock purchase plan, education reimbursement
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Number of Employees
5,001-10,000 employees
