Senior CAPA Engineer

Philips • Orlando, FL

4d • $87,000 - $139,200 • Onsite

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 the commitment 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 apply 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 accommodation for this position. How we work together: We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an Office role. About Philips: We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody, everywhere, has access to the quality of healthcare that we all deserve. Do the work of your life to help improve the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. Learn more about our culture. Philips Transparency Details: The pay range for this position in Orlando, FL is $87,000 to $139,200 The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here. Additional Information: US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Orlando, FL. May travel up to 10%. #LI-PH1 This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

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 accommodation 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 the commitment 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 apply 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 our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees