Senior Quality Engineer

Company: Stryker Corporation
Location: Flower Mound
Posted on: June 12, 2021

Job Description:

About Stryker

Stryker is one of the world's leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. 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

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

As a Senior Quality Engineer, you will provide quality engineering support and direction in quality assurance, control, and preventative activities. You will focus on continuous improvement of products and processes, advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers.

• You will work closely with operations and the business functions to ensure quality performance of product and processes.
• You will work closely with customers, sales/marketing/field personnel, and cross-functional teams to address top quality issues.
• You will have oversight of NC/CAPA execution and act as a mentor in problem-solving and root-causing activities.
• You will lead and participate in the development and improvement of the PFMEA & inspection processes for existing products.
• You will review and execution of change management activities.
• You will maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, take action as necessary.
• You will support execution and analysis of complaints and product field actions.
• You advocate of Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.
• You proficient understanding of risk management practices and concepts.
• You will participate and interface in internal audits providing effective narrative and description of topic of expertise, participate in external audit preparation building confidence and proficiency in interactions.
• You will assist in the development and review of process and equipment validation/qualification. Build proficiency in validation processes.
• You will support manufacturing transfers, supplier changes, and PPAP to minimize quality issues.
• You will be responsible for initiation, internal containment, and support of commercial holds for potential product escapes.

What you need

• Bachelor's in electrical engineering or related discipline required
• Minimum of 2+ years of experience in a regulated industry, ideally with an electrical focus
• MS, CQE, or CRE preferred, Six Sigma Green or Black belt preferred.
• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.
• Understanding of US and International Medical Device Regulations highly desired
• Familiarity with ISO 13485, GDP, GMP desired.
• Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics) desired.

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.

Keywords: Stryker Corporation, Flower Mound , Senior Quality Engineer, Other , Flower Mound, Texas