Staff NPI Quality Engineer

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

Dedicated achievers. 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.

Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.

What you will do

As a Staff NPI Quality Engineer you will apply professional expertise and to work independently with cross functional teams leading process strategy and decisions for new product initiatives.  You will provide quality engineering expertise and direction in quality assurance, control and preventative activities in the development and introduction of new products, processes and technologies, with focus on quality systems development, risk management, test & inspection strategies and product reliability.

  • You will advocate and lead the execution of quality activities in process development, verification, validation, design transfer and post market release phases whilst ensuring compliance to regulation and standards.
  • You will communicate effectively with all Customers, Stakeholders, leadership and project teams in delivering on quality, transfer and NPI project goals.
  • You will provide oversight and approval of NC & CAPA, mentor in problem solving and root causing activities.
  • You will work collaboratively with strategic partners, such as Advanced Operations, Design Assurance,
  • You will work with product development, and suppliers to achieve strategic initiatives.
  • You will participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.
  • You will ensure regulatory requirements are incorporated into projects and processes upon launch and transfer to sustaining.
  • You will use statistical methods and application and apply statistical techniques to ensure the development of robust, predictive quality systems which are easily transferable and maintainable.
  • You will assist in the development, responsible for review & approval of process and equipment validation/qualification.
  • You will Interface with suppliers during NPI phase in developing quality systems and resolving any quality issues.

What you need

  • Bachelor of Engineering - Biomedical, Mechanical, or related field required
  • 4+ years of experience is required, additional preferred
  • Expertise in PFMEA, validation programs, design transfer/new product innovation, and supplier quality.
  • Understanding of manufacturing prints and tolerancing, GD&T
  • Internal Quality Auditor Qualification preferred (ISO 13485, CFR 820 or comparable industry standard and regulatory requirements)

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.

Company
Stryker
Posted
06/10/2021
Salary Range
$70,000.00 - 102,000.00
per Year
Salary range estimated by
Location
Mahwah, NJ 07495, US