Sr. Quality System Manager

Job TitleSr. Quality System Manager

Job Description

In this role, you have the opportunity to

The Senior Quality System Manager is responsible for the organization's ISO17025 Quality Management System, independent accreditation's, quality partnerships (ANAB, CSA, UL, etc.), audits, corrective actions, and continuous improvements. The primary focus is the tactical/strategic management of the ISO17025 quality system and related management activities, so as to maintain compliance and improve operational excellence of the Andover Standards and Reliability Center (ASRC). This position will develop, monitor, and maintain control of all aspects of the quality system, including execution of internal audits, hosting external audits, driving proactive and corrective actions, improving processes, and verifying that records are accurate and properly vaulted per process and per Good Documentation Practices (GDP). The candidate will interface with internal customers and ASRC Project Engineers/ Managers on a daily basis across multiple shifts.

You are responsible for

  • Maintain, develop, and improve the ASRC ISO17025 quality system. Provide periodic Quality Management System Reviews and develop action plans to address gaps.
  • Drive and lead periodic internal and external ISO17025 audits and certifying agencies audits (e.g. ANAB, CSA, UL, etc.). Maintain all accreditation requirements. Develop detailed plans to address corrective and preventive audit actions.
  • Lead a team of engineers/ technicians (indirect reports) to identify areas of improvement within the quality system, open CAPAs when needed, and drive corrective and preventive action per defined schedules.
  • Develop and drive a long-term strategic vision plan to improve operational efficiency through improved processes, training development, integration of new workflow tools, and vaulting tools.
  • Develop and drive a comprehensive peer review plan to further minimize/ eliminate documentation errors and Good Documentation Practices (GDP) issues.
  • Organize and drive PCMS site wide training on product related standards when needed. Work closely with Group Q&R, BUs leaders, and ASRC managers to ensure visibility of key product standards.
  • Drive and maintain the ASRC preventive maintenance program.
  • Final quality review and vaulting of final test reports and other compliance records.
  • Review customer feedback and drive improvements through ASRC management team.
  • Develop, publish, and maintain Master Project listing for all improvement, corrective and preventive actions. Hold monthly reviews with ASRC management team for proper resource support and timely closure.
  • Work closely with ASRC director to ensure awareness to critical delays, critical gaps, customer concerns and/or feedback.
  • Drive and lead, in conjunction with ASRC management team, to develop AOP investments plan to execute on quality system improvements.
  • Influence, where possible, the ISO17025 standard. Leverage Philips to provide direct input into the review process for future revisions.

You are a part of

Sr. Quality System Manager for the Andover Standards and Reliability Center (ASRC). This is a key and critical role within the ASRC Group at Philips Healthcare in Andover, MA. This is an opportunity to be part of an experienced, winning team that performs product safety, EMC compliance, reliability verification, rapid prototype development (Model Shop), and Calibration services for all medical product lines within Philips Andover.

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

  • BSEE (or related engineering discipline) with 10+ years' experience in managing complex quality systems/ engineering projects/ regulated environment.
  • Strong knowledge of ISO17025 Quality System in a Test / Calibration Laboratory or similar quality system standard in a regulated environment is required, medical preferred.
  • Experienced leading audits, certified ISO17025 lead auditor preferred.
  • Project management development with experience in product compliance verification engineering, preferably for medical devices.
  • Experienced in reading, analyzing and interpreting quality project schedules, general business data, and solid knowledge of spreadsheets to make proactive project decisions.
  • Demonstrated success in presenting quality project problems, schedules, and the ability to respond quickly to questions from all levels of ASRC management including internal customers and recommending solutions to urgent issues.
  • Demonstrated exceptional organizational skills with the ability to handle and prioritize multiple projects simultaneously in a timely manner within a fast-paced and dynamic environment.
  • Strong written and oral business communication skills; must be able to write and understand complex reports, follow oral and written instructions, and speak effectively with technical groups.
  • Candidate must demonstrate strong attention to detail and ethical behaviors.
  • Strong interpersonal skills; ability to relate to and work with diverse groups of people.
  • Candidate must have a high level of interpersonal skills to handle sensitive and confidential situations and continually requires demonstrated poise, tact and diplomacy.
  • Demonstrated success in LEAN improvement projects.
  • Highly passionate and positive infectious attitude who strives for high performance, product quality, and with attention to details.
  • The ability to work well in a team and possessing the skills and the ability to work independently to get things done efficiently and timely.
  • Proficient in standard office computer tools: Microsoft Office, Word, Excel, Project, PowerPoint and Visio.
  • Experience working in an FDA and ISO13485 regulated environment, and under the Philips site Quality System desirable.

In return, we offer you

Sharpen your talents with new challenges in our dynamic organization. As a market-driven company, we're used to listening to our customers & apply the same thinking to our employees. We offer a competitive salary, outstanding benefits and flexibility in a career with a positive and supportive atmosphere in which to develop your talents further.

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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