The Director-Quality Programs will play a critical leadership role within Philips’ Sleep & Respiratory Care-Patient Safety & Quality Organization by driving the movement of products/materials on hold, non-conforming reports and providing centralized tracking for products and materials.Your role:
Hold Release Strategy & Execution: Will Partner with cross-functional teams (Quality, Regulatory, Medical, Supply Chain, and Business Segment Leaders) to define clear release criteria when a new product hold is initiated. Develop and execute a structured plan to orchestrate efforts for product/material release in alignment with QMS and compliance standards. Ensure all necessary risk assessments, testing, and regulatory requirements are met before release.
Oversight of Quality Plans & Timelines: Will monitor progress against commitments and timelines outlined in quality plans. Proactively identify risks to meeting deadlines and work with teams to implement corrective actions. Provide regular status updates to leadership and escalate issues when necessary.
Product Hold Management & Transparency: Will identify all products and materials currently on hold, ensuring clear visibility across teams. Establish a defined timeline and necessary actions to release products/materials from hold. Maintain a centralized tracking system for holds and ensure alignment with business priorities.
You're the right fit if:
You’ve acquired a minimum of 10+ years’ experience working in FDA regulated medical device quality environments, with a deep understanding of ISO 13485 QMS, compliance, and regulatory requirements related to medical device product holds/releases (highly preferred).
You have proven experience in cross-functional Program leadership, problem-solving, and drivingcomplex projects to completion.
You’ve demonstrated strong analytical skills with the ability to interpret data, assess risk, and develop actionable strategies.
You have detailed knowledge of US and international standards-21 CFR Part 820, ISO 13485, EU-MDR and other relevant regulatory/global standards, with the ability to act as a subject matter authority/enforce all relevant compliance and regulatory standards.
You’re able to make strategic decisions, communicate effectively with Internal/External stakeholders, teams and leaders to clearly define and communicate release criteria when a new product hold is initiated.
You have a minimum of a Bachelor’s Degree (Required) in Engineering, Quality, Regulatory, Life Sciences or comparable disciplines. Master’s Degree desired.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position (https://www.careers.philips.com/na/en/office/remote-sedentary-work-physical,-cognitive-and-environmental-pce-job-requirements) .
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 company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an Office role.About Philips: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. healthcare that we all deserve. Do the work of your life to help improve the lives of others.
Learn more about our business (https://www.philips.com/a-w/about.html) .
Discover our rich and exciting history. (https://www.philips.com/a-w/about/our-history.html)
Learn more about our purpose. (https://www.philips.com/a-w/about/environmental-social-governance/our-purpose)
Learn more about our culture. (https://www.careers.philips.com/na/en/our-culture-philips-careers)
Philips Transparency Details:
The pay range for this position in Murrysville, PA is $153,000 to $246,000.
The pay range for this position in Cambridge, MA is $172,000 to $275,000.
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 (https://www.philipsusbenefits.com/) .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.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 Murrysville, PA or Cambridge, MA.
May require travel up to 10%.
#LI-PH1It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.Equal Employment and Opportunity Employer/Disabled/Veteran