Philips QMS Engineer 

United States, New York, New York 

565559113

QMS Engineer
Job Description

Responsible for driving CAPA activities from issue identification to closure, effectively project managing all CAPA activities, ensuring the quality of CAPA record content and representing CAPAs during audits and CAPA Review Board meetings

Your role:

• Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring.
• Project manage 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 (e.g. Pride problem solving).
• Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.
• Ensure CAPA documentation clearly defines actions necessary to proceed with improvement actions.
• 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.
• Independently produces and completes CAPA records both in the corresponding software database or via hard copy.
• 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.
• Implementing Philips’ requirements and best practices as well as industry best practices by working with the global CAPA team, Center of Excellence and CAPA coaches.
• Responsible for communicating compliance gaps to the site and ensuring adequate evidence of closure.
• Collecting the data for and routinely reporting on CAPA metrics.

You're the right fit if:

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

• 3+ years of related experience in medical device or other regulated industry.
• Bachelor’s degree in an engineering or scientific-related field or equivalent demonstrated strong technical competence.
• Demonstrated ability to properly execute and explain root cause analysis techniques.
• Knowledge to train on documentation of objective evidence required for closure of CAPA plans.
• Strong communication skills including written, verbal and listening skills.
• Strong organizational skills, ability to multi-task and effectively prioritize your workload.
• Applied knowledge of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, and ISO 9001, and ISO 14971
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this

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 healthcare that we all deserve. Do the work of your life to help improve the lives of others.

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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion .

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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.