Director-Global Quality Programs

Koninklijke Philips N.V • Bothell, WA

300d • $172,000 - $275,000 • Onsite

About The Position

In late January, Philips announced that Bridgefield Capital signed an agreement to acquire Philips' Emergency Care business which includes leading brands and products like HeartStart AEDs, Intrepid and DFM100 monitor defibrillators, Tempus monitor and Tempus ALS systems, and Corsium and ECI informatics solutions. We expect the transaction to close at the end of 2025. With Bridgefield's support and building on our 40+ year legacy of growth and innovation in emergency medical technology, the Emergency Care business will continue passionately pursuing our mission of saving lives, lowering the cost of healthcare, and advancing the science of resuscitation while serving the public access AED, EMS, military, and hospital market segments. In this Director-Global Quality Programs role and as part of an agile company that has the dedicated resources needed to achieve its strategic goals, you'll have every opportunity to grow both personally and professionally and potentially make an even bigger impact on the acute care space - as well as on the consumers, patients and healthcare workers who depend on these innovative life-saving solutions.

Requirements

• Minimum of 10 years' experience in Quality Operations/Supply Chain Assurance within FDA regulated (ISO 13485) medical device environments.
• Product experience with AED's/Defibrillators or other Class III Devices containing medical electrical equipment/software highly desired.
• Proven experience leading global Quality Operations/Supply Chain Assurance programs and transformational initiatives.
• Extensive experience and knowledge of global medical device regulations, guidance, and applicable standards including ISO 14971, ISO 13485, 21CFR 820, EU MDR.
• Proven track record of working/communicating effectively with Global cross-functional teams and with internal/external stakeholders.
• Minimum of a Bachelor's Degree in a Quality discipline, Supply Chain Management, Engineering, Clinical/Life Science or similar disciplines.

Nice To Haves

• Master's Degree desired.
• ASQ Certifications desired.

Responsibilities

• Leads and directs all aspects of Global quality operations/assurance program activities, including Emergency Care business separation/divestiture quality transformation.
• Contributes to strategic planning involving mission, vision, and policies to ensure alignment and effectiveness in organizational decision-making.
• Supports supplier/3rd party qualification, audits, and assessment process.
• Develops and executes requirements, conditions, and enablers within the Emergency Care business.
• Leads planning, staffing, budgeting, expense management prioritization.
• Establishes a supply chain quality assurance practice at the delivery model level.
• Manages and monitors quality compliance issues and conflict resolution.
• Supports product recall procedures and oversees all aspects of the recall process.

Benefits

• Generous PTO
• 401k (up to 7% match)
• HSA (with company contribution)
• Stock purchase plan
• Education reimbursement

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Ambulatory Health Care Services
• Education Level: Bachelor's degree