Staff Quality Engineer
| Company | Stryker |
|---|---|
| Location | Flower Mound, TX, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Mid Level, Senior |
Requirements
- Bachelor’s degree in science, engineering, or related discipline.
- Minimum of 4 years of experience in quality engineering with a solid background in quality concepts, including risk management, non-conformance/corrective and preventive actions (NC/CAPA), audits, and statistics.
- Experience in following GDP and cGMP standards such as ISO 13485 with a comprehensive understanding of both US and international medical device regulations.
- Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.)
Responsibilities
- Provide leadership and direction in quality assurance, control, and preventative activities.
- Champion and lead initiatives and projects to enhance quality performance within the business and for our customers.
- Mentor and provide technical direction across multiple areas of expertise.
- Ensure compliance with regulations and standards.
- Collaborate closely with operations and business functions to ensure quality performance of products and processes.
- Engage with customers, sales/marketing/field personnel, and cross-functional teams to address top quality issues.
- Lead investigations during concession management and review change management activities.
- Interpret KPI trends and drive continuous improvement processes.
Preferred Qualifications
- Bachelor’s degree in biomedical engineering, Electrical Engineering, Mechanical Engineering preferred.
- Master’s degree, CQE, CRE, Six Sigma Green or Black Belt certifications.
- Experience in identifying necessary changes and take ownership of the global impact assessment process, ensuring comprehensive evaluation and management of all potential impacts.