Philips Director Global Complaint Management 

United States, Washington, Bothell 

397643256

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.

Your Role:

• Provide oversight and leadership of assigned complaint handling and regulatory reporting organizations. Foster a team culture where team members feel valued, listened to, encouraged to grow, and try new things.
• Drive effective preparation for audits and timely resolution to all audit non-conformances including internal and external. When necessary, partner with legal manufacturing sites, Philips compliance team, and trusted partners to support creation/submission/closure of responses to FDA/Competent Authority observations to ensure a positive outcome for Philips. Communicate with the FDA and other regulators, as needed.
• Ensure robust dashboards/performance management reports are maintained for each complaint handling organization and that CAPAs are owned/driven to closure with urgency, high quality investigations, with root cause and corrective actions in place. Provide visibility to management and escalation management and resolution, when necessary.
• Collaborate with leadership in Quality, Medical Affairs, R&D, Service, Manufacturing, OEMs, among others, to ensure timely escalations of critical complaints, and investigations are thorough and timely. Work cross-functionally and in collaboration with other senior leaders within the business and with outsourcing partners develop and lead transformations, performance management and strategic roadmap. Engage with business units on upcoming product launches and ensure resources are budgeted and in place.
• Member of the Quality Leadership team and support strategic plans/objectives for the Global Complaint Management Organization, as well as developing strategic changes needed to ensure timely & accurate complaints investigation and closure, including on-time regulatory reporting globally.

You're the right fit if:

• You’ve acquired a minimum of 10+ years’ experience in FDA regulated quality/regulatory environments, with a focus on Post Market Surveillance / Complaint Handling / Regulatory Reporting / Quality Operations and a minimum of 4 years’ experience leading/managing teams in a fast paced, high visibility environment. Product experience with AED’s/Defibrillators or other Class III Devices containing medical electrical equipment/software highly desired.
• You have proven leadership experience delivering on strategic commitments and transformation across various aspects of Quality, with experience in Business/Organizational separations/divestitures highly preferred.
• You've demonstrated a collaborative customer focus; with high performance behavior of shared accountability, listening and learning, sense of urgency, entrepreneurial, trust and influence management, self-growth, empowerment, and continuous improvement.
• You have prior FDA and other regulatory audits/inspections experience is required. Experience corresponding to regulatory inquiries associated with regulatory device reporting (i.e. MDR, MDV, etc.) is required
• You have extensive experience/knowledge of most regulations relative to Post Market Surveillance activities and reporting, such as: ISO 9001/13485/14971, FDA Regulations (21CFR (803, 806, 820, etc.)), MDSAP, JPAL, Medical Devices Directive (93/42/eec, 98/79/EC)), and EU MDR.
• You have a minimum of a Bachelor’s degree in Quality, Engineering, or equivalent
• 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. 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 Bothell, WA is $172,200 to $275,520.

• 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 Bothell, WA.
• May require travel up to 20%.