About the Role
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).
