Philips Senior Quality Program Manager-Integrated Supply Chain 

United States, New York 

12838763

The Senior Quality Program Manager provides cross-functional technical quality/compliance program leadership to programs/projects associated with Quality Management Systems (QMS)-QMS implementation, PQMS changes, continuous improvement/transformation, EU MDR, UDI Labeling, MDSAP, and Warehousing/distribution programs.

Your role:

• Will manage and provide oversight to key Quality Management Systems/Q&R projects, ensuring complete visibility up and down the chain of Q&R operations across Products Manufacturing model within Philips.
• Responsible for developing the quality project management funnel in alignment with site Q&R leaders and Products Manufacturing stake holders to ensure projects driven by quality are timely, effective and operational.
• Will align with site and Operations Q&R leaders to deliver timely KPIs and resolution to areas of improvement.
• Monitors and facilitates work associated with Products Manufacturing Quality projects cross0functionally, including development, operations, quality, regulatory marketing, and provides direction and guidance to core and extended team members to achieve unit or project goals.
• Will plan, manage, execute, and be responsible for project timeliness, supporting key stake holders across Product manufacturing sites and central Philips entities.
• Responsible for ensuring program objectives are determined, achieved, communicated with management and product owners, integration of multiple functions is facilitated, logistics are effectively coordinated, and budgets are adhered to.

You're the right fit if:

• You have a minimum of 7+ years’ experience in full-cycle, global Quality Program/Project management within FDA regulated medical device Manufacturing /Supply Chain environments, with a focus on Quality Management Systems (QMS), including ISO 13485 QMS implementation, CAPA processes, Nonconformance, Calibration, Process/Production Controls, Warehousing, distribution etc.
• You have demonstrated experience leading and implementing quality management system processes and IT tools such Change Control Processes, Management Controls, Non-Product Software management, Training program, Auditing process, non-conformance processes such as CAPA program and Complaint Management Process in prior experience including systemic improvements across businesses and manufacturing sites.
• You’re experienced in Continuous Quality Improvement/transformation practices, including training, experience and/or certification in Lean/ Six Sigma (SS Blackbelt preferred), TCM, CTQ principles, DFX, Kaizen, and Hoshin’s are highly preferred as the Sr. PM will be required to manage, facilitate and support Kaizen, Hoshin’s and daily management.
• You have detailed knowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation, Canadian Medical Devices Regulation (SOR/98-282), etc.
• You have proven experience utilizing data analytics/ Quality KPI’s to assess project/program/team performance and identify process/continuous improvement and Remediation opportunities.
• You’re highly experienced in all aspects of E2E global Program/Project Management including cross-functional leadership, change/risk management, KPI’s, budgeting, timelines, resource allocation, project strategy, reporting, communication, etc..
• You’re able to effectively communicate, influence and build relationships with cross-functional team members, internal/external stakeholders at all levels, suppliers, and manage/facilitate FDA, competent authorities, Regulatory Agencies and Notified Body audits and inspections.
• You have a minimum of a Bachelor’s Degree (Required) in Engineering (Mechanical preferred), Quality or related disciplines. PMP, PMBOK, SAFe certifications desired.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody, everywhere, has access to the quality of healthcare that we all deserve. Do the work of your life to help improve the lives of others.

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Philips Transparency Details:

• The pay range for this position in Latham, NY is $114,750 to $183,600.

• US work authorization is a precondition of employment.
  The company will not consider candidates who require sponsorship for a work-authorized visa,
  now or in the future.
• This role may require travel up to 10%.