Staff Quality Engineer (Hybrid)

    • Stryker
  • Flower Mound, TX
  • Posted 42 days ago | Updated 11 hours ago

Overview

On Site
Full Time

Skills

Verification and validation
Medical devices
Healthcare information technology
Professional development
Use cases
Health care
Microsoft Power BI
Data Analysis
Performance monitoring
Risk management
Process improvement
Statistics
Problem solving
Quality assurance
Mechanical engineering
Lean manufacturing
ISO 13485
SolidWorks
Collaboration
Research
Leadership
Recruiting
Brand
Design
Analytical skill
ROOT
FDA
Filing
Sales
Metrics
Data
Trackwise
Dashboard
Management
Reporting
Inspection
Routers
Science
Testing
Manufacturing
Electrical engineering
GDP
GMP
Insurance
Finance

Job Details

Why engineering at Stryker?

At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.

Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team:

We are proud to be named one of the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

Stryker is hiring a Staff Quality Engineer (Hybrid) in Flower Mound, Texas, home to Stryker Communications! Our communications team is dedicated to optimizing care environments through the iSuite integrated operating room. As part of the Quality team, customers and patients are at the heart of everything we do. Our Staff Quality Engineers maintain our brand of high-quality products.

As a Staff Quality Engineer, you will work with a team passionate about resolving product issues, improving product quality, and participating in design improvement projects.

Work Flexibility: Hybrid. This role requires reasonable proximity to our Stryker facility in Flower Mound, TX. You should be comfortable working 3+ days a week onsite.

Who we want:
  • Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
  • Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.


What you will do:
  • Reviews and determines reportability of complaints to FDA and international regulatory authorities.
  • Supports the review and filing of Medical Device Reports (MDRs) and international Vigilance Reports.
  • Works closely with Sales Representatives and health care professionals to obtain additional information.
  • Monitors quality, completeness, and timeliness of complaint investigations.
  • Writes customer response letters.
  • Contributes to achieving team performance metrics and goals.
  • Collect data from multiple sources such as Trackwise and translate the data into meaningful Power BI Dashboards and visualizations.
  • Author and peer review Post market plans/reports on products sold worldwide.
  • Provide technical expertise in data analysis, data preparation and performance monitoring.
  • Build, manage and maintain reports, dashboards and visualizations as needed.
  • Communicate key findings to business partners and leadership throughout the organization.
  • Help develop automated solutions for dashboard and report generation.
  • Lead risk management activities to ensure the highest level of product and process quality.
  • Lead quality system maintenance by identifying and correcting deficiencies in procedures and practices.
  • Partner with cross-functional project teams to lead product and/or process improvements.
  • Utilize standard statistical analysis and problem-solving techniques to determine product acceptance limits, establish process parameters, resolve quality problems, etc.
  • Develop, review, and approve inspection plans, routers, and product drawings for new products.
  • Provide support and direction for other Quality Engineers.
  • Participate in collection of initial market feedback, provides complaint's data on new products and address early concerns.
  • Contribute to the completion of final design verification and validation.


What you need:

Required
  • Bachelors of Science in Engineering or related discipline
  • 4+ years of experience in Quality Engineering


Preferred
  • Design Quality Engineering experience
  • Strong knowledge in testing and Verification & Validation (V&V)
  • Experience working in a regulated industry (Medical Device Manufacturing is strongly preferred)
  • Electrical/Mechanical engineering experience preferred.
  • Lean manufacturing experience is strongly preferred.
  • Must be willing to work as part of a multi-site team, with some travel required.
  • Have a good understanding of engineering and quality concepts / theories. Familiarity with ISO 13485, GDP, GMP concept
  • Knowledge of Risk Based and statistical concepts.
  • Knowledge of Solid Works


About Stryker

Our benefits:

  • 12 paid holidays annually
  • 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.

For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits

About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company 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 130 million patients annually. More information is available at stryker.com.

Know someone at Stryker?
Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program on our referral page

Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.