Q&R Manager, CAPA Systems
In this role, you have the opportunity to
Drive CAPA activities from issue identification to closure; effectively project manage all CAPA activities; ensuring the quality of CAPA record content; and representing CAPAs during audits and CAPA Review Board meetings.
You are responsible for
- Point of contact for the site CAPA team
- Monitor site level work load for each facilitator
- Provide prioritization guidance to team members
- Assist in CAPA process Improvements
- SME and Back Room/Front Room support for internal/ external audits
- Work with functional manager to identify and obtain quarterly feedback for team members from various sources
- Coach CAPA facilitators who may need assistance / partner with for CAPAs to include training the team
- Ensure CAPA training to key users of the process is conducted
- Between 25-50% CAPA facilitation include facilitation of high priority CAPAs (such as inspection related and health/safety related)
- Own site related CAPAs on CAPA
- Responsible for doing independent reviews as needed for CAPAs
- Provide weekly report of workload by facilitator including:
- Quality of work output from the team
- All feedback heard from internal customers
- Major concerns
- Escalation of key issues
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 the leadership. 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.
Here at Philips WE ARE Working Together for a Better Tomorrow
Philips' dedication to enriching lives is reflected in our company, our solutions, and a commitment to our people. Philips products lead to improved healthcare, faster diagnosis and better patient outcomes. Philips employees change lives every day.
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.
Thanks to our employees, we are at the forefront of the Healthcare industry. Healthcare providers, backed by our many market leading solutions, are able to diagnose confidently, improve care, and increase the quality of life for patients across North America each and every day.
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 in 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 relent pursuit to improve the quality of life for the billions of people the Philips brand touches each year.
Specific skill requirements
- Bachelor’s degree plus 5 years’ of similar work experience desired
- Ability to understand and analyze complex problems
- Demonstrated knowledge 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 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.
- Strong people management skills, including ability to manage CAPA engineering team for HRC
- Ability to analyze data
Ready to start improving lives by putting your personal skills & passions to work? Apply Today! Not yet ready to apply? That’s okay! Learn more about us by joining our Talent Network on LinkedIn or following us on Twitter at @PhilipsJobsNA.
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
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.
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