In this role, you have the opportunity to
Performing various post-market functions related to Post Market CAPAs, audit management, and recall reporting and tracking. This position will support both MA&TC Post Market and report to the Director of MA&TC Post Market Operations. This position is required to support MA&TC Post Market Consent Decree activities.
You are responsible for
Support the coordination of all Post Market audit activities (FDA, Third Party, External and Internal) as it relates to recall management (SME in relevant areas as appropriate).
Represent and manage to closure all Post Market CAPAs relating to recall management. This could be as the CAPA owner and/or PM functional group representative on other related CAPAs
Participate in Post Market process improvements when required due to EU MDR, CD, etc.
Assist in the management of recall responses, recall file documentation and recall file completion as needed
Participate in Field Action Review Board meetings when applicable
Act as a trainer/lead to Post Market process and tools if applicable
Assist when needed on compliance for key documentation (HHE, Correction and Removal documents, field status documents, etc.)
Based on experience, provide relevant feedback and insight to the FCO teams to ensure regulatory compliance
Frequently interact with functional area supervisors, peer group managers, and market management. Often leading the cooperative effort among members of the FCO project team.
Follow processes and operational policies in selecting methods and techniques for obtaining solutions
Support external and internal audit of the post market group when needed for recall management
Support and (if required) participate in Philips recall compliance initiatives as a MA&TC Q&R recall expert representative
To succeed in this role, you should have the following skills and experience
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
BS in technical discipline or equivalent education, experience, training
Project Management skills (Six Sigma)
At least 5 years of Quality and/or Regulatory experience in a medically regulated and technical environment
An understanding of 21 CFR Part 820 (QSR), Part 7, 806, 810 (Recalls, Corrections and Removals)
An understanding of the appropriate medical device standards (21 CFR 820, ISO 13485)
Demonstrated strong organization skills
Proficiency using Philip’s tools (SAP, Trackwise)
Proficiency in Microsoft Excel and Microsoft Project is required.
Must be able to work under pressure to meet regulatory reporting time frames and company requirements.
Strong sense of responsibility and self-motivation with demonstrated ability to function independently and in a group environment.
Requires the proven ability to consistently meet and/or exceed goals.
Must be capable of making commitments, setting priorities, and delivering results on time.
Able to exercise sound judgment within Philips using standard operating procedures and policies to determine appropriate action to achieve objectives.
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 .
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without 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.