Senior Quality Program Manager-Integrated Supply Chain

Job Title

Job Description

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.

Youre 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.
• Youre 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 Hoshins are highly preferred as the Sr. PM will be required to manage facilitate and support Kaizen Hoshins 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 KPIs to assess project/program/team performance and identify process/continuous improvement and Remediation opportunities.
• Youre highly experienced in all aspects of E2E global Program/Project Management including cross-functional leadership change/risk management KPIs budgeting timelines resource allocation project strategy reporting communication etc..
• Youre 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 Bachelors 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 position.

How we work together:

We believe that we are better together than a part. For our Office-based teams this means working in-person at least 3 days per week. Onsite roles require full-time presence in the companys facilities. Field roles are most effectively done outside of the companys main facilities generally at the customers or suppliers locations. This is an Onsite role.

About Philips:

We are a health technology company. We built our entire company around the belief that every human matters and we wont 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.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

Philips Transparency Details:

• The pay range for this position in Latham NY is $114750 to $183600.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills experience business needs geographical location and internal equity.

At Philips it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

In addition other compensation such as an annual incentive bonus sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program which includes a generous PTO 401k (up to 7% match) HSA (with company contribution) stock purchase plan education reimbursement and much more. Details about our benefits can be found here.

Additional Information:

• 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%.

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This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.