Director, Quality Programs (PMO) Ambulatory Monitoring & Diagnostics

The Director Quality Programs (PMO)-AM&D is responsible for strategic leadership and execution of global quality vision by leading critical quality programs and coordinating activities across multiple disciplines ensuring alignment with business objectives and regulatory requirements. provides strategic leadership in driving critical quality/compliance programs associated with Quality Management Systems (QMS)-QMS implementation PQMS changes/transitions and continuous improvement/transformation programs.

Your role:

• Provides strategic guidance to managers in different areas identifying opportunities for quality improvement and innovation and fostering a culture of quality excellence and continuous improvement throughout the organization.
• Tackles complex issues by analyzing situations with a deep understanding of the organization contributing to the development and refinement of organizational objectives and principles to drive effective solutions.
• Ensures the overall regulatory submission process for product compliance ensuring compliance with applicable regulations such as FDA EU-MDR and other regulatory requirements such as ISOCFR 820 and maintains consistent guidelines and policies across all products and operations.
• Enforces robust regulatory processes and harmonize them across functions establishing a comprehensive management review process including routine reporting on regulatory compliance activities to maintain organizational awareness.
• Assists in succession planning and comprehensive talent management supporting employee selection performance management compensation management and career development in alignment with organizational operational goals.
• Demonstrates leadership experience in at least one operating process domain such as product development or supply chain and various aspects of quality showing familiarity with business process management frameworks and regulatory strategy development.
• Identifies and evaluates fundamental issues within the functional area interact with executive-level management and oversee activities such as planning staffing budgeting managing expense priorities and proposing methodological changes to improve efficiency and effectiveness.
• May include Person Responsible for Regulatory Compliance (PRRC) responsibilities such as verifying compliance of devices with regulations maintaining technical documentation overseeing post-market surveillance system for effective data collection for maintenance of device safety and performance and fulfillment of vigilance reporting obligations and sign statements confirming that investigative devices comply with general safety standards.
• Will plan manage execute and be responsible for program 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 10 years experience leading full-cycle global Quality Programs within FDA regulated medical device Manufacturing /Supply Chain environments with a focus on Quality Management Systems (QMS) including ISO 13485 QMS implementation/transitions CAPA processes Nonconformance Process Controls etc.
• Youre highly experienced in all aspects of E2E global Program Management including 5 years in strategic/cross-functional leadership change/risk management KPIs budgeting timelines resource allocation project/quality strategy reporting communication etc..
• You have demonstrated experience leading and implementing quality management system processes and tools such Change/Management Controls Training programs Audit/ non-conformance processes such as CAPA programs and systemic improvements across businesses and manufacturing sites.
• 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 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 Bachelors degree in Engineering Quality Life Sciences or a related technical field. Lean/ Six Sigma and ASQ-CQM 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 Office-Based 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 Phoenix AZ is $162000 to $258000
• The pay range for this position in Linwood PA is $170000 to $270000.

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.

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.

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.
• Company relocation benefits will not be provided for this position. For this position you must reside in or within commuting distance to Linwood PA OR Phoenix AZ.
• 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.