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Philips

3.3 | Andover, MA | Hospital & Health Care | 10000+ Employees
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Posted 3 weeks ago on Nov. 14, 2019

Sr. Quality Engineer (CAPA) - Investigations

Full-time in Cambridge, MA
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See at-a-glance how well companies like Philips support the things that are important to you.
Paid Time Off
4.0
Flexible Work Hours
3.8
Ability to Telecommute
3.8
The People You Work With
3.7
Wellness Initiatives
3.6
Philips is a hospital & health care company headquartered in the Andover, MA area with 10000+ employees. Philips has a 3.3-star InHerSight Score, based on 1,084 ratings from 75 current or former employees. 23 employees have left comments about their experience working for the company on InHerSight.

Job Title

Sr. Quality Engineer (CAPA) - Investigations

Job Description

In this role, you have the opportunity to

Drive progress on QMS Improvement and Maintenance, including active support and ownership of department CAPAs.

You are responsible for

  • Triage and perform preliminary investigation of newly opened CAPA Requests
  • Represent CAPA function during inspections, audits and CAPA Review Board meetings.
  • Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.
  • Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement.
  • May lead a team of individual investigators to support the Monitoring Analytics
  • Must be able to address multiple CAPAs simultaneously
  • Mentor junior team members to develop their abilities to lead and document root cause investigations. 
  • Independently produces and completes CAPA record, ensuring compliance with applicable external regulations and internal standards, while assuring agreement within the organization.
  • Responsible for maintaining and updating CAPA business processes.
  • Ensures disagreements within CAPA records are reconciled, including appropriate escalation as required.
  • Represent CAPAs during inspections, audits and CAPA Review Board meetings.
  • Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.
  • Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available and tasked to the projects.
  • Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement.
  • Other tasks as assigned

To succeed in this role, you should have the following skills and experience

  • Bachelor’s degree in an engineering or scientific-related field or equivalent technical experience
  • At least 5 years’ experience with CAPA and at least 10 years' experience in the medical device industry
  • Able to understand and analyze complex problems, including software and hardware design issues.
  • Ability to address multiple high-profile projects simultaneously
  • Demonstrated knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations
  • Experience writing for a legal audience and/or defensive writing techniques (e.g.,  FDA's "Write it Right”)
  • Strong understanding of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, EU MDR, CFDA, ISO 9001 and ISO 14971.
  • Demonstrated ability to partner with the business and effectively interact with and influence employees, and managers on all levels.
  • Project Management skills, including ability to project manage all CAPA activities.
  • Ability to analyze data and apply statistical techniques.
  • Excellent written and verbal communication skills

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 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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