Philips Manager, Quality Systems in Bothell, Washington

Quality Systems Manager

Your Challenge

Within the global consumer products business managing the QMS compliance in the US and Canada and providing recommendations to management and functional business units. Business sells Health Canada and FDA Class I and Class II products. Firm command of FDA regulations and CMDR a must. CPSC and CPSIA knowledge and experience a plus. A major focus of this position will be working within a global network to communicate and address QMS challenges applicable to the US, Canada and EU.

Lead the Quality Management System at Philips Oral Health Care Ensure that the Quality Management System is created in compliance with the appropriate Philips Policies, standards and regulations required by the products supported. Take a lead role in the Quality Management Planning activity of changes to ensure compliance, outsourcing and Philips programs Provide Leadership in steering quality management systems activities with ownership of Quality Management System Management Review and creation process, Corrective/Preventive Action System, and document control and training integration. Act on required reporting to respective regulatory and notified bodies for such activities as site registrations, device licenses, changes in product types, changes in activities at the site, and changes in personnel.


Define and maintain the Quality Management System structure to ensure compliance to Philips Policies, ISO 9001, ISO 13485, 21 CFR 803, 806 and 820, Canadian Food, Drugs, and Medical Devices Regulations (CMDR)and EU Medical Device Regulations. Maintains, enforces, and manages a compliant and effective QMS for the activities in scope, as well as for effective and lean QMS structures and documents for Q&R processes at all levels. Establishes the Philips Quality Management System(PQMS) and manages its deployment. Ensures proper audit planning and schedule meets the requirements of internal policies and external regulations. Establishes and executes a transition plan for all QMS in scope while maintaining compliance and effectiveness throughout the duration of the transition to the PQMS. Leads/participates in the maintenance of the quality documents until such time as they are determined to be no longer applicable as part of the PQMS transition. Ensures the addition and management of any local QMS documents in line with the evolution of the PQMS. Ensures training and training registration as per the QMS and generates training content for local QMS documents as necessary.

Your Team

You will report to the Head of Philips Quality Management System- BG Health and Wellness, Headquartered in Amsterdam, Philips Personal Health team is made up of a highly talented and multi-national workforce that is approximately of 25,000 strong, and spans over 50 countries with sales in more than 100 countries. We are proud to claim market leadership positions for cutting edge solutions in the business areas of Personal Care, Oral Care, Shaving and Grooming, Mother & Child Care, and Coffee. Philips is home to popular brands such as Sonicare, AirFloss, Norelco, Avent, and Saeco.

Our Offer

Philips Personal Health business offers rich, new consumer experiences that meet consumers’ desire for wellness and pleasure throughout each part of their day and during key milestones throughout their life. We are a highly entrepreneurial organization, passionate about developing innovations that meet consumer’s personal health & well-being needs in a unique way, relative to their Mind, Body, and Appearance. The Personal Health Group is one of three market-driven sectors within Royal Philips Electronics that delivers lifestyle solutions aimed at improving the lives of 3 billion people a year by 2025. Named one of the Top 50 Happiest Companies in America, Philips provides a unique opportunity for each employee to create their legacy in life through their work in a way that is personally meaningful to them.

We Are Looking For

  • Bachelor’s degree in a scientific or technical field

  • 7+ years of experience in the medical device industry

  • Strong working knowledge of GMP’s and other FDA regulations

  • Experienced manager with a minimum of 5 years of experience leading teams and delivering on organizational objectives

  • Experience managing a team to deliver business application implementation projects, including experience as an active contributor on projects with scheduled deliverables.

  • Experience validating application activities.

  • Solid Analytical skills - demonstrated ability to trouble-shoot complex process/system issues.

  • Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.

  • Strong IT skills, including MS Word (advanced user), Excel, Visio, and related MS Office applications.

  • Proven analytical capabilities

  • Excellent communication, organizational and project management skills

  • Successful experience working with cross functional teams across multiple work locations

  • Effective written and oral communications skills and computer skills required

  • Network oriented and able to interact with different business functions and can work within numerous systems

  • Work cooperatively in a team environment

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.