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Job Title QMS Engineer
Job Description If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance.In this role, you have the opportunity toMaintains a compliant, lean and effective MS/QMS. Partners across the business to continually improve and standardize SRC's MS/QMS structure, documents and systems. Monitors, measures, and drives in-scope functional & process performance (both on-going and strategic).You are responsible for- Ensures training program compliance and timely training execution
- Ensures external and internal audit readiness and provides support during external and internal audits
- Reviews QMS and Engineering changes as well as Quality plans to ensure compliance/conformance to 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
- Managing the strategic improvement processes ('breakthrough Program') in the Business (One Page Strategy, Hoshin Plan)
- 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
- Establishes operational objectives and work plans, and delegates assignments to subordinates
- Establishes and assures adherence to schedules, work plans and performance requirements
- May manage or oversee individual contributors
- Bachelor's degree plus a minimum of 2 years of related experience in the medical device or another regulated industry and in the application of automated technology, particularly GAMP 5
- 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.
- Experienced Engineer with proven success within teams and delivering on organizational objectives
- 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
- Project Management (development of project plans, status meetings, project reporting, etc.) and organizational change management
- Strong communication skills; ability to prioritize and manage multiple simultaneous programs/projects
- Strong IT Skills
- Ability to travel up to 25%
- Position to be strategically located at the Pittsburgh CoE
- ID: #20676503
- State: Pennsylvania Pittsburgh 15289 Pittsburgh USA
- City: Pittsburgh
- Salary: USD TBD TBD
- Job type: Permanent
- Showed: 2021-10-05
- Deadline: 2021-11-08
- Category: Architect/engineer/CAD