Philips Sr. Quality Engineer/CAPA Engineer in Bothell, Washington
• Conduct 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 providing CAPA deliverables per project timelines.
• Document all phases of CAPA activity in compliance with applicable standards including 21 CFR part 820.100 and ISO 13485, and procedural requirements.
• Maintain CAPA records, keeping them in a state of audit readiness.
• 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.
• Guide cross functional teams assigned to product CAPAs to ensure verification and/or validation of corrective and preventive actions are effective and do not adversely affect the finished product.
• 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.
• Provide periodic CAPA trending data to management for review.
• Serve as TrackWise tool SuperUser/expert.
Specific skill requirements for this role include:
· Bachelor’s degree with > 5 years of related experience quality systems engineering; or a Master’s degree with < 3 years of related experience quality systems engineering.
Bachelor’s degree in an engineering or scientific related field.
5 to 10 years related experience in the medical device industry.
Demonstrated ability to effectively interact with and influence employees, and managers on all levels.
Must be goal-oriented and proactive in problem solving, coupled with creativity and a high energy level.
Strong understanding of FDA regulations, International laws and regulations.
Strong written and verbal communication skills.
Strong project management skills.
Must be able to function with minimal supervision.
This role comes with a competitive compensation offering and a generous holiday / vacation offering, but that’s not all. Quality is right on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformation changes. You will be empowered to drive high quality, ground breaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role’s mission, you will have an array of diverse career options open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.