Stryker is hiring a Senior Quality Engineer for our TMJ portfolio located in Ventura, California.
This is an onsite position based in Stryker's Ventura office five days per week.
As the Senior Quality Engineer, you will join a manufacturing site focused on patient-specific medical devices where quality engineering plays a critical role in maintaining process integrity and product performance. This position supports the development, manufacturing, and continuous improvement of custom temporomandibular joint prostheses in a regulated environment. You will work cross-functionally to drive quality outcomes, ensure compliance, and support operational excellence.
This role operates within a highly regulated manufacturing environment producing patient-specific implants and requires close coordination with internal teams and suppliers to meet quality, compliance, and production objectives.
What you will do
Partner with operations and cross-functional teams to monitor and improve product and process quality performance using defined KPIs and trend analysis.
Own non-conformances and corrective and preventive actions, ensuring root cause investigation and closure within established timelines.
Disposition non-conforming product in material review processes and initiate quality records as required.
Execute workstreams independently to meet defined project timelines, while coordinating with cross-functional partners to align on deliverables and support project execution as needed.
Evaluate and approve manufacturing and supplier change requests, including production part approval processes and validation activities.
Support audits (internal and external) by providing documentation, data, and subject matter expertise to demonstrate compliance.
Apply statistical methods and process controls to assess variation, improve capability, and maintain consistent manufacturing outcomes.
Contribute to process validation, inspection method development, and risk management activities to ensure compliant and robust operations.
What you need
Required
Bachelor’s degree in engineering, science, or related discipline.
Minimum 2 years of experience in quality engineering, manufacturing, or related field.
Experience working in a regulated environment with knowledge of Good Manufacturing Practices.
Preferred
Minimum 3 years of experience in medical device manufacturing or quality engineering.
Master’s degree or professional certification (e.g., Certified Quality Engineer or Certified Reliability Engineer).
Six Sigma Green Belt or Black Belt certification.
Knowledge of international medical device regulations and standards (e.g., ISO 13485).
US10 : $85,500 - $142,500 USD Annual
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