Post Market Q&R Project Specialist

Job Title

Post Market Q&R Project Specialist

Job Description

In this role, you have the opportunity to
In this role, you have the opportunity to frequently interact with Complaint Investigators, Service Order Reviewers, Quality System Analysts, CAPA facilitators, training administrators, and Philips Management. You will participate in and manage investigation, implementation, and effectiveness monitoring for multiple CAPAs and projects for post market surveillance in MA&TC.

You are responsible for
CAPAs:

  • Extract information from the complaints database and provide evaluation as to whether these complaints indicate compliance with process.
  • Communicate with investigators to resolve the non-compliances.
  • Participate in problem solving for systemic problems.
  • Assist in process changes, including process writing and EC processing and including assisting in training/coaching
  • Monitor the complaints database to monitor the completion of non-compliance remediation.
  • Monitor the complaint database to monitor the improvements in process compliance
  • You may have the opportunity to assist in correcting complaint documentation after full training as an investigator.
Projects:
  • Participate in project teams
  • Obtain and analyze data as needed for projects
  • Communicate, written and oral, as needed for projects
  • Assist in process changes, including process writing and EC processing and including assisting in training/coaching

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
  • 4+ years' experience Medical Device and or other regulated industry (Pharma, IVD).
  • Basic knowledge of QSR, 21 CFR part 803, 820, ISO13485, Med Dev, ISO9001, etc.
  • 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.
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Contact

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