Staff Quality Engineer

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 high-quality 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 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.
  
  

What you need:

Required Skills:

• 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.)
  
  

Preferred Skills:

• 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.
  
  

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.