Sr. CAPA Quality Engineer
Sr. Quality Engineer (CAPA) - Investigations
As the incumbent of this Quality & Regulatory (Q&R) role within Philips, your challenge will be to guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.
Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech focused company, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA) and European Union Medical Device Regulation (EUMDR).
- Responsible for performing timely, detailed CAPA engineering tasks including assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis and quality problem solving.
- May lead a team of individual investigators to support the Monitoring Analytics
- Lead and mentor cross-functional teams with the implementation of appropriate root cause analysis techniques (e.g. Pride problem solving).
- Must be able to address multiple CAPAs simultaneously
- Responsible for maintaining and updating CAPA business processes.
- Independently produces and completes CAPA record, ensuring compliance with applicable external regulations and internal standards, while assuring agreement within the organization.
- Ensures disagreements within CAPA records are reconciled, including appropriate escalation as required.
- Project manage all aspects of assigned CAPAs including gaining the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines.
- Represent CAPAs during inspections, audits and CAPA Review Board meetings.
- 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 and tasked to the projects.
- Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement.
We are looking for:
A person who is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience challenging, often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life billions for the billions of people Philips brand touches each year.
- Demonstrated expert knowledge of tools and techniques required to perform thorough root cause analysis and document strong investigations.
- Able to understand and analyze complex problems, including quality management system and software / hardware design issues.
- Strong understanding and working knowledge of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001, ISO 14971, EU Medical Device Regulations (EUMDR).
- Demonstrated ability to partner with the business and effectively interact with and influence employees, and managers on all levels.
- Strong Project Management skills, including ability to project manage all CAPA activities.
- Ability to analyze data and apply statistical techniques.
- Excellent written and verbal communication skills
- Bachelor’s degree in an engineering or scientific-related field or equivalent technical experience
- At least 5 years’ experience with CAPA and at least 6 years’ experience in a medical device or other FDA-regulated industry.
- ASQ Certification such as Certified Quality Engineer or Certified Quality Auditor, or DfSS Green Belt / Black Belt.
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, transformational 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.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
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