Senior Staff Quality Engineer, Supplier Management EU MDR in Portage, MI at Stryker Corporation

Date Posted: 10/4/2019

Job Snapshot

Job Description

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Supplier Quality Lead located in Kalamazoo, Michigan

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.

Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.

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 imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

User-focused creators. People who imagine with the user in mind, developing technology that helps change patients’ lives.

What you will do:

EU MDR is a new EU regulation which requires all Medical Device’s to comply as per the required timelines. Supplier Quality Lead role lies within the Supplier Workstream to support implementation activities Divisionally. The following activities are responsibilities within the role

  • Remotely Lead indirect Quality Engineer reports based Globally
  • Report to the Program Manager escalations, risks and project status
  • Execute Global Project activities
  • Liaise with Sourcing partners
  • Support all activities required by Divisions to support the execution of EU MDR to meet deadlines

What you need:

  • Bachelor’s Degree in Science, Engineering or related field
  • Minimum 7 years’ experience
  • Supplier quality experience
  • Quality, engineering, compliance or working in a regulated environment.
  • Experience in medical device industry preferred.
  • Experience working onsite developing suppliers preferred.
  • Experience conducting supplier audits and internal audits preferred.
  • Quality systems experience; ISO13485, EU MDR & ISO9001 experience preferred.
  • Strong knowledge of quality planning tools:  APQP, PPAP/FAI, FMEA, MSA, Control Plan, & Control Charts preferred
  • Demonstrated process knowledge in assigned commodity (i.e. plastics, metals, electronics, PCBAs, etc.) is desired

Work From Home: Yes

Travel Percentage: 20%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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