In this role will lead the Sleep & Respiratory Care (SRC) corrective and preventive action (CAPA) process to ensure compliance with the required medical device quality standards and regulations (FDAs Quality System Regulation 21 CFR Part 820.100 (QSR/cGMP), ISO9001, ISO13485, MDD, CMDR/CMDCAS and other requirements).
You are responsible for
Drive continual improvement of the CAPA process through best practice implementation of CAPA quality system procedures (QSPs) and appropriate CAPA software to ensure compliance.
Provide guidance and expertise in development of the CAPA process to provide optimum value to the organization for continuous improvement and prevention of defects. Ensure risk management principles are exercised in the CAPA process.
Support the deployment of the PQMS CAPA process as appropriate.
Review and approve CAPAs for adequacy and effectiveness. Remediate CAPA files as necessary to ensure compliance.
Chair the monthly CAPA review board meetings to ensure the CAPA process remains effective.
Ensure that CAPA status reports are distributed to management on a routine basis.
Participate or assist in internal and external audits (notified body, FDA, customers, etc.) as needed.
Provide coaching and mentoring to CAPA facilitators and CAPA owners to ensure development and continual improvement.
Team with PQMS and other Business Groups to ensure best practices for CAPA are implemented.
Perform various Quality Systems functions on an as-needed basis to support business needs (preparation of quality management review data, support external audits, manage KPI’s, etc.)
You are part of
Philips is a diversified technology company, focused on improving people’s lives through meaningful innovation. With a century of history and more than 450 innovative products and services, we are ready to meet today’s challenges in healthcare by creating solutions that deliver better care to more people at lower cost.
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.
Skills and experience
B.S. in Engineering, Life Sciences or other similar technical field.
The successful candidate will have knowledge and experience in CAPA systems.
Must have knowledge of the regulations and international standards that apply to the medical devices industry.
2 or more years of experience implementing and/or executing CAPA processes in a medical device (regulated) environment.
Teaming and influencing, managing metrics, holding CAPA owners accountable for meeting deliverable dates.
Planning and Organization, Initiative, Ability to Influence, Commitment to Quality and Continual Improvement.
We offer you
Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what’s next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy.
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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . 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 at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .
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.