Senior Quality Engineer
Company: Stryker Corporation
Location: Flower Mound
Posted on: June 12, 2021
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
- Collaborative partners. People who build and leverage
cross-functional relationships to bring together ideas,
information, use cases, and industry analyses to develop best
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
- You will work closely with customers, sales/marketing/field
personnel, and cross-functional teams to address top quality
- 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
- You will review and execution of change management
- You will maintain KPIs for monitoring of process and/or product
quality, perform analysis, and interpret trends, take action as
- 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
- You proficient understanding of risk management practices and
- 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
- 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
- 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
- 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?
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for this position. Learn more about our employee referral
Keywords: Stryker Corporation, Flower Mound , Senior Quality Engineer, Other , Flower Mound, Texas
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