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Philips · 1 day ago

Director of Design Quality Engineering-Oral Healthcare

Bothell, WA

Full-time

Onsite

Director/Executive

$172K/yr - $275K/yr

10+ years exp

Philips is a health technology company dedicated to improving healthcare access for everyone. The Director of Design Quality Engineering will oversee the design control process and lead the implementation of advanced Quality Engineering practices to ensure product quality and compliance throughout the product lifecycle.

B2BConsumer ElectronicsElectronicsLightingWellness

No H1B

Responsibilities

Develops and executes robust product V&V and process validation strategies using and developing capabilities in advanced statistics to ensure smooth, compliant product launches

Leads the full design lifecycle, from value proposition creation to design transfer, ensuring global regulatory and quality compliance

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 and compliance

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, biocompatibility, and drives talent development initiatives to strengthen quality systems and organizational capability

Qualification

Design Quality EngineeringISO 13485Risk Management-FMEADesign Verification/ValidationBiocompatibilityQuality Improvement InitiativesPost Market SurveillanceTechnical LeadershipSix Sigma CertificationStakeholder Management

Required

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, Biocompatibility (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 regulatory compliance

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)

You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position