Philips Quality Systems Engineer in Bothell, Washington

Quality Systems Engineer

Your Challenge

This role will manage the Quality Management System compliance within the global consumer products business in the US and Canada and provide recommendations to management and functional business units. 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.

Responsibilities

  • Define and maintain the Quality Management System procedures 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.

  • Manage Philips Quality Management System related deployments and implementations.

  • Ensures proper audit planning and schedule meets the requirements of internal policies and external regulations.

  • Establishes and executes a transition plan for all QMS related activities in scope while maintaining compliance and effectiveness throughout the duration of the transition to the Philips Quality Management System.

  • Leads/participates in the maintenance of the quality documents until such time as they are determined to be no longer applicable as part of the Philips Quality Management System transition.

  • Ensures the addition and management of any local QMS documents in line with the evolution of the Philips Quality Management System.

  • Ensures training and training registration as per the QMS and generates training content for local QMS documents as necessary.

  • Maintains, enforces, and manages a compliant and effective CAPA Process for the activities in scope, as well as for effective and lean structures and documents for Q&R processes at all levels including CAPA compliance to regulations and standards ensured through proactive support and facilitation of the CAPA activities with individual CAPA owners

  • Managing site CAPA program and leading CAPA Review Board meetings.

  • Establishes the Philips CAPA Management System and manages its deployment including IQ-OQ-PQ Validation for web-based designed tool for the CAPA system. Work on validation test protocols, conversion/migration of data, mapped configuration requirements mapped to corresponding regulation requirements as applicable for 21 CFR Part 11 and 820

  • Ensures proper CAPA planning and schedule meets the requirements of internal policies and external regulations.

  • Leads/participates in the maintenance of the CAPA documents and matrices for tracking trending and reporting.

  • Ensures the addition and management of any local QMS documents in line with the evolution of the CAPA.

Your Team

You will report to the Head of Philips Quality Management System for Health and Wellness, headquartered in Amsterdam. The business sells Health Canada and FDA Class I and Class II products. The 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 that delivers lifestyle solutions aimed at improving the lives of 3 billion people a year by 2025. 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

  • A minimum of 3+ years of experience in the medical device industry

  • Working knowledge of GMP’s and other FDA regulations and CMDR

  • CPSC and CPSIA knowledge and experience a plus

  • Project management experience is required

  • 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

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

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

  • Effective written and oral communications skills

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

  • 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.

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