Staff Specialist, Quality Management System in Kalamazoo, MI at Stryker Corporation

Date Posted: 12/2/2019

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 Staff Specialist, Quality Management System located in Michigan, Kalamazoo.

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.

What you will do:

  • Facilitate and drive the execution of the Quality Management System as a Process Owner.
  • Provide guidance for other Process Owners to maintain compliance of QMS.
  • Lead and participate in internal and external quality audits as required.
  • Support the coordination of any major changes to the business and quality system.
  • Processes documentation changes utilizing one-PLM.
  • Support training needs for new Quality System to the organization.
  • Understand regulatory requirements and translate into internal business and quality system documentation

What you need:

  • Bachelor's Degree Required (concentration in a technical field, quality engineer, technical writing preferred)
  • 5+ years of relevant experience
  • Technical writing experience in a regulated industry.
  • Previous process mapping experience is preferred
  • Previous auditing experience with one of the following (ISO/CFR/JPAL/CMDCAS/MDD, etc.) Is preferred
  • Excellent communication, time management, and organization skills with high emphasis on attention to detail.
  • Ability to successfully interface with various departments and personnel
  • Ability to work independently and motivated to perform at a high-level without constant supervision
  • Ability to handle multiple projects on an ongoing basis
  • Ability to adhere to necessary processes within a regulated environment

Work From Home: Occasional

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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