Senior Quality Engineer (Onsite)

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

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.