Philips Senior QMS Engineer 

United States, Pennsylvania 

666081368

Senior QMS Engineer

You are responsible for:

• Ensures external and internal audit readiness and provides support during external and internal audits.
• Supports certification relationship with Notified Body as appropriate.
• Reviews QMS and Engineering changes as well as Quality plans to ensure compliance/conformanceto FDA regulations and other Regulatory Agency and consensus standard requirements.
• Ensures adequate service levels and quality for document control, records management, software validation, CAPA, Quality Planning, Management Review QMS processes, monitoring and assurance of process performance.
• Represents QMS/Engineering Change processes and records to regulatory agencies as required.
• Owns QMS CAPAs, develops adequate and defensible root cause analyses and action plans; completes plans to schedule.
• Actively assists in managing a program of CAPAs; accountable for timely and comprehensive corrective and preventive management of issues/opportunities.
• Actively assists in managing a program of Quality Plans; accountable for plan accuracy and on-schedule plan closure.
• Proactively identifies areas of emerging risk and advises on directions for future areas of analysis/development.
• Acts as QMS competence expert, coaching and developing skills and knowledge within the QMS team.
• Supports the move toward the Philips Excellence Process Framework for the transformation the business to the Philips Business System including the Philips Integrated IT Landscape
• Promoting Q&R awareness level as determined within the organization.
• Managing the enforcement of standardized quality systems across the Business; ensuring deployment of strategic projects & E2E PIL Solutions to schedule
• Establishes an effective Management Review process, including routine reporting.
• Participates in Quality & Regulatory initiatives as a cross functional contributor.
• Creates PQMS transformation awareness and establishes the Philips Business System, manages all activities under the PQMS governance.

To succeed in this role, you’ll need a customer-first attitude and the following:

• Minimum of a Bachelor’s degree in an Engineering, Quality, Regulatory or Scientific discipline.
• Minimum of 7+ years’ experience in the FDA regulated Medical Device or HealthTech industry.
• Proven experience in the application of automated technology, particularly GAMP 5 preferred.
• Understanding and application of appropriate global medical device regulations, requirements, and standards, including FDA’s 21 CFR 820, ISO 13485, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, ANVISA, ISO 14971, ISO 9001, and others including familiarity with the European Medical Device Regulation MDR 2017/745.
• Proven experience in Quality Management System processes, including cross sector or business process standardization, ensuring effectiveness and efficiency while maintaining compliance with worldwide regulations.
• An ability to successfully communicate and educate Quality Management System regulations, policies, and strategies to teams at all levels of the organization.
• Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.
• Advanced Analytical skills: demonstrated ability to troubleshoot complex process/system issues.
• Strong communication skills.
• Ability to prioritize and manage multiple simultaneous programs/projects.
• Ability to travel up to 25% (travel mainly to otherSleep & Respiratory Caresites in the Pittsburgh area-Murrysville, New Kensington, Mt Pleasant.
• * US work authorization is a precondition of employment. The company will NOT consider candidates who require sponsorship for a work-authorized visa.

In return, we offer you:

Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.

There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.The way we work, and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.