Director of Design Quality Engineering-Oral Healthcare

Job Title

Job Description

The Director of Design Quality Engineering will play a critical role within Philips Oral Healthcare organization 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 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.

Youre the right fit if:

• 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.
• Youre 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/KPIs 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 bachelors degree (Required) in Quality Engineering or Scientific discipline (required). ASQ CQE/CRE and Six Sigma certification (desired).
• You must be able to successfully perform the following minimum Physical Cognitive and Environmental job requirements with or without accommodation for this position.

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 companys facilities. Field roles are most effectively done outside of the companys 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 wont 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.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

Philips Transparency Details:

• The pay range for this position in Bothell WA is $172000 to $275000.

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.

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 Bothell WA.
• May require travel up to 10%.

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This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.