Director of Design Quality Engineering-Oral Healthcare

Koninklijke Philips N.V • Bothell, WA

2d • Onsite

About The Position

The Director of Design Quality Engineering will play a critical role within Philips Oral Healthcareanization by directing the End-to-End design control process, and leading the adoption of advanced Quality Engineering practices, fostering a culture of quality excellence and continuous improvement.
Your role:
Develops and executes robust product V&V and process validation strategies using and developing capabilities in advanced statistics to ensure smooth,pliant product launches.
Leads the full design lifecycle, from value proposition creation to design transfer, ensuring global regulatory and qualitypliance.
Promotes advanced Quality Engineering practices across teams to drive continuous improvement and excellence.
Integrates Post Market Surveillance and reliability data into lifecycle processes to improve product quality andpliance.
Oversee design evaluations and root cause analyses to proactively resolve quality issues and uphold quality and regulatory standards.
Directs audit readiness and strategic responses to inspections, ensuring full alignment with internal and external quality and regulatory expectations.
Leads teams working on risk management, CAPA, bipatibility, and drives talent development initiatives to strengthen quality systems andanizational capability.

Requirements

• You have a minimum of 10+ years' experience in Product Design Quality/Control with extensive experience in both ISO 13485 Medical Device/Technology and ISO 9001, with extensive design/development experience in Class I medical device, consumer goods and cosmetics.
• You have proven experience in strategic/functional team leadership, including mentoring, budgeting, training, succession planning, hiring, performance management and technical/professional development of team members.
• You have proven expertise in all aspects related to Design Quality/Controls, with experience in Risk Management-FMEA/ISO 14971, Reliability, Bipatibility (ISO10993-1) and Hazardous Substance Management.
• You're experienced in both hardware and software development lifecycles, design controls and defending design and development in external audits.
• You have experience leading strategic quality improvement initiatives, utilizing data/KPI's and integrating insights from Post Market Surveillance (PMS), quality, and reliability data into all stages of the product lifecycle, driving ongoing enhancements in product quality and regulatorypliance.
• You have extensive experience in Design Verification/Validation planning, test design, product reliability, Root Cause Analysis (RCA) test/regression plans, associated test protocols/reports, issue tracking/resolution and auditing Design History Files (DHF).
• You have the proven ability to cultivate and maintain strong relationships with internal and external stakeholders, at all levels, by sharing knowledge, providing insights, and ensuring alignment with software quality standards, regulatory requirements, and project objectives.
• You have a minimum of a bachelor's degree (Required) in Quality, Engineering or Scientific discipline (required).

Nice To Haves

• ASQ CQE/CRE and Six Sigma certification (desired).

Responsibilities

• Develops and executes robust product V&V and process validation strategies using and developing capabilities in advanced statistics to ensure smooth,pliant product launches.
• Leads the full design lifecycle, from value proposition creation to design transfer, ensuring global regulatory and qualitypliance.
• Promotes advanced Quality Engineering practices across teams to drive continuous improvement and excellence.
• Integrates Post Market Surveillance and reliability data into lifecycle processes to improve product quality andpliance.
• Oversee design evaluations and root cause analyses to proactively resolve quality issues and uphold quality and regulatory standards.
• Directs audit readiness and strategic responses to inspections, ensuring full alignment with internal and external quality and regulatory expectations.
• Leads teams working on risk management, CAPA, bipatibility, and drives talent development initiatives to strengthen quality systems andanizational capability.

Benefits

• Employees are eligible to participate in ourprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (withpany contribution), stock purchase plan, education reimbursement and .
• Details about our benefits can be found .

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees