Associate Manager, Quality Engineering

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Stryker is hiring an Associate Manager, Quality Engineering (Hybrid) for our communications Division supporting Stryker’s Endoscopy products. This manager will lead the global business processes related to product returns, failure analysis and support post-market product surveillance activities. Candidate must reside within a commutable distance to Flower Mound, Tx, and is expected to be onsite at the facility multiple 3-4 days/week. 

What You Will Do

Provide leadership and subject matter expertise to ensure that an effective system is successfully implemented and maintained to ensure compliance in global markets; requires strong communication and problem-solving skills as well as a solid understanding of applicable global regulations and standards.

Lead the implementation and maintenance of systems ensuring global regulatory compliance.

• Provide engineering support focused on quality assurance and continuous improvement of products and processes.
• Oversee all post-market reporting, including Medical Device Reporting (MDR) and Medical Device Vigilance (MDV).
• Interpret and recommend modifications to operational procedures for ongoing regulatory compliance.
• Maintain up-to-date knowledge of global regulatory requirements for adverse event reporting.
• Train Technical Service and Support teams on compliance with post-market surveillance requirements.
• Collaborate with key partners to ensure global policy adherence and process improvements.
• Provide strategic planning and tactical direction to meet quality objectives and predefined metrics.
  
  

What You Will Need

• Bachelor’s degree in Engineering, Science, or a related field
• Minimum 6 years of experience
• Knowledge of global medical device regulations, such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO14971
  
  

Preferred

• Experience in Quality, Regulatory, or R&D within the medical device industry
• 4 years of experience managing technical personnel or complex activities
  
  

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.