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Staff Quality Engineer, Post Market

$77.7k - $178.6k
Full-time

Stryker

Stryker is hiring an Staff Quality Engineer, Post Market in Flower Mound, CA supporting our Endoscopy division to provide technical leadership across product quality, risk management, and continuous improvement initiatives. In this role, you will serve as a key quality subject matter expert, driving complex investigations, leading cross-functional problem-solving efforts, and influencing product and process improvements throughout the product lifecycle. You will partner with engineering, manufacturing, operations, and commercial teams to ensure compliance, enhance product performance, and deliver quality solutions that improve customer and patient outcomes.

What you will do:

  • Lead and prioritize multiple product quality and design improvement initiatives, providing technical leadership across complex projects and business-critical issues.

  • Serve as a quality and customer advocate by driving urgent customer support, resolving escalated product concerns, and ensuring timely issue resolution.

  • Lead complex investigations of customer complaints, leveraging root cause analysis, post-market data, and risk assessments to drive product safety, reliability, and performance improvements.

  • Own the development, validation, and implementation of product and design changes, partnering closely with engineering, manufacturing, and suppliers to ensure successful execution.

  • Drive software and hardware quality improvements by leading field issue investigations, supporting defect resolution, and influencing release strategies to address customer needs.

  • Analyze and trend quality, reliability, and post-market surveillance data to identify emerging risks, inform decision-making, and drive proactive continuous improvement initiatives.

  • Partner directly with customers and clinical stakeholders through field observations and site visits to understand product use, workflow challenges, and opportunities for innovation.

  • Provide technical mentorship and quality leadership across the organization while supporting Quality Systems activities, new product development efforts, and strategic business initiatives, including acquisitions.

What you need :

Required Qualifications 

  • Bachelor's degree in Engineering or related

  • Minimum of 4+ years of experience in engineering, design, quality, usability/human factors, or related 

Preferred Qualifications 

  • Engineering degree in Electrical, Computer Science, Software, or Biomedical Engineering with a heavy emphasis on Electrical or Software

  • 4-7 years of related experience in R&D/design, design assurance, usability/human factors, quality, systems engineering 

  • Hands-on design experience with software or hardware 

  • Root cause analysis and troubleshooting experience 

  • Familiarity with ISO 14971, ISO 13485, ISO 60601, ISO 62366, and/or ISO 62304 

  • Commitment to excellence and high standards. 

  • Excellent written and oral communication skills. 

  • Strong organizational, problem-solving, root cause and analytical skills. 

  • Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm. 

  • Proven ability to handle multiple projects and meet deadlines. 

  • Good judgment with the ability to make timely and sound decisions. 

  • Acute attention to detail. 

United States of America Pay Ranges:

  • Puerto Rico : $77,700 - $129,500 USD Annual
  • USN : $89,300 - $148,800 USD Annual
  • US5 : $93,800 - $156,200 USD Annual
  • US10 : $98,200 - $163,700 USD Annual
  • US15 : $102,700 - $171,100 USD Annual
  • US20 : $107,200 - $178,600 USD Annual
  • US30 : $116,100 - $193,400 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.

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.
Vacancy posted 11 hours ago
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