Job TitleCAPA Engineer
In this role, you have the opportunity to
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
You are responsible for
- Serve as a resource to and facilitate CAPA investigations including data analysis, root cause analysis and developing/implementing corrective action plans.
- Ensure activities performed in the CAPA process are accurately documented in the CAPA tool and that all timeframes for reporting or resolution are met.
- Maintain and manage positive working relationships while assisting in all stages of CAPA management and resolution.
- Serve as a point of contact in processing, monitoring, reporting, and resolving problems and process improvements.
- Maintain personal competency in all aspects of CAPA, including policies and procedures.
- Provide back up to the Q&R Engineer 4 - CAPA (CAPA Leader) for daily operation of the CAPA system.
- Ensures that appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design
- Validates key design inputs like: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs
- Provides effective oversight of the execution of the Quality Plan , any Risk Management activities, and of all design related activities during the product/system lifecycle
- Performs independent technical assessment on product quality performance and post-market product quality analysis
- Can Lead quality related problem solving and root cause analysis during design and manufacturing
- Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required
- Act as a single point of contact (person assigned to project team) responsible to ensure that hardware design meets quality and compliance standards for every milestone
You are a part of
As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.
To succeed in this role, you should have the following skills and experience
Specific skill requirements for this role include:
- Bachelor's degree or equivalent work experience
- 3+ years relevant experience
- Strong multi-cultural communication skills, both written and verbal.
- Knowledge of general Q&R support tools (e.g. CAPA, documentation control, complaint, ERP) and ability to use.
- Good understanding of CAPA processes including investigations, technical writing and documentation
- Experience with Six Sigma Process Excellence tools, training and/or certification
- Knowledge of medical device regulations and standards such as 21CFR820 and ISO 13485
- Experience in FDA regulated environment and medical device
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. Learn more by watching this video.
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.
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.
If you forgot your password, you can click the Forgot Password button on the Sign In screen to reset it. In case of technical difficulties, please send an email to [email protected]
(Note: To ensure fairness and legal compliance in our recruitment processes, only technical issues will be monitored through the above inbox. Please do not submit resumes or applications to this email, as they will not be reviewed. Only applications received through the online application process will be considered.)
Meet Some of Philips's Employees
Jose engineers the specific system level requirements for the Philips Sonicare oral healthcare products. He makes certain the detailed design of each device over-delivers on customer expectations every time.
Back to top