Quality Engineer (f/m/d) CAPA
Updated: 29 Mar 2020
In this role you have the opportunityto 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.
You are responsible for
- Successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA).
- 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 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.
- 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.
We are looking fora 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. To succeed in this role, you should have the following skills and experience
- Able to understand and analyze complex problems, including software and hardware design issues.
- Demonstrated kledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations.
- Strong understanding of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971.
- 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 3 years’ experience with CAPA