Staff Quality Engineer
Staff Quality Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
Join Stryker as a Staff Quality Engineer and become an integral part of our Endoscopy Quality team. At Stryker our customers and patients are at the core of everything we do. As a Quality Engineer you will uphold our commitment to delivering highquality products that reflect the excellence of our brand.
Workplace Flexibility: Hybrid Role:You will need to live within commuting distance to our Flower Mound TX office. You will need to be in the office 3 days a week but you will have the flexibility to work from home on the other days.
What you will do:
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 crossfunctional teams to address top quality issues.
Lead investigations during concession management and review change management activities.
Interpret KPI trends and drive continuous improvement processes.
What you need:
Required Skills:
Bachelors 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 nonconformance/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.)
Preferred Skills:
Bachelors degree in biomedical engineering Electrical Engineering Mechanical Engineering preferred.
Masters 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.
Required Experience:
Staff IC
Employment Type
Full-Time
