Post Market Surveillance Process Specialist
Post Market Surveillance Process Specialist
In this role, you have the opportunity to
Manage CAPAs, projects, and processes related to post market surveillance. You will interact with CAPA facilitators, Philips Management, Complaint Investigators, Service Order Reviewers, Quality System Analysts, and training administrators.
You are responsible for
- Manage investigation of possible systemic deficiencies in post market surveillance processes, tools, and training
- Guide CAPA teams in documenting root cause for observed deficiencies
- Define and implement containment as needed
- Propose action plans for CAPAs, as warranted
- Propose effectiveness checks and monitor CAPA effectiveness
- Participate in project teams
- Represent MA&TC Post market surveillance in Philips-wide projects
- Communicate, written and oral, as needed for projects
- Lead efforts to improve and/or streamline post market surveillance process
- Develop and deliver training for post market surveillance processes.
You are a part of
A Quality Team which enables meaningful innovation to our customers by partnering with and guiding the business to achieve world class quality and full regulatory compliance. We do this while creating a great workplace for our people to realize their career aspirations.
To succeed in this role, you should have the following skills and experience
- BS in a technical discipline or equivalent education, experience, training
- 6+ years' experience Medical Device and or other regulated industry (Pharma, IVD).
- Basic knowledge of QSR, 21 CFR part 803, 820, ISO13485, Med Dev, ISO9001
- Good Verbal and written communication skills
- Ability to query data/analyze data
- Analytical skill and focus on detail
- Teamwork in and outside Q&R
- Provide conflict resolution
- Utilize creative problem solving techniques.
- Consistently being available to support our team in meeting all business objectives.
- Support internal and external audits.
- Quality and/or Regulatory experience in a medically regulated and technical environment
- Demonstrated strong organization skills
- Must be able to work under pressure to meet process/project 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
In return, we offer you
At Philips, we strive to make the world healthier and more sustainable through innovation, and our goal is to improve the lives of 3 billion people a year by 2025. This position offers the opportunity to impact worldwide regulatory compliance and directly improve the customer and patient experience.
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 .
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 firstname.lastname@example.org .
(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
Software Engineer—Cambridge, MA
Ankita works with the Innovation Group to develop software which assists Philips customers, improving the day-to-day workflows of clinicians so that they can concentrate on their patients.
Back to top