Quality Engineer, Service in Kalamazoo, MI at Stryker Corporation

Date Posted: 6/27/2018

Job Snapshot

Job Description

The Quality Engineer will support the Service (Repair) Depot to ensure adherence to Stryker’s Quality System while minimizing customer downtime and identifying opportunities for continuous improvement for existing products and provide input on Service for new product development.

  • Fully support the Quality needs of the Depot Service, Field Service, Loaner, Refurb, and Non-Serviced Device teams. This includes validation support and non-conformance documentation.
  • Conduct risk assessments on product and process nonconformances to determine patient/user health risk; develop and document action plan to address discrepancies.
  • Evaluate and document product nonconformances in a timely manner in order to minimize customer downtime.
  • Provide input for product development of serviceable product; support validation of new equipment and fixtures; create new quality inspection procedures for product acquisitions intended to be serviced.
  • Facilitate and manage team of subject matter experts to generate appropriate technical documentation as appropriate.
  • Review and comprehend applicable Quality System Procedures, ensuring compliance to the procedures. Create or update procedures as necessary.
  • Prepare monthly presentations for cross-department assessment utilizing various sources of data from ERP systems, complaint databases and customer feedback.
  • Prioritize and manage multiple projects within process/design specifications and budget restrictions.
  • Participate in cross-functional teams to identify and define product/process improvement opportunities.
  • Initiate, communicate, manage, and lift Local (Ship) Holds;
  • Partner with supporting engineering staff to resolve line-down issues.
  • Conduct internal audits of the Service unit and investigate audit findings.
  • May travel as needed to customer accounts to provide product expertise and observe utilization practices

Sedentary work:

  • Exerting up to 10 pounds of force occasionally and/or a negligible amount of force to lift, carry, etc.
  • Very good visual acuity.
  • Must be able to communicate with large groups of people
  • Must be able to review printed materials
  • Ability to use common office equipment (e.g. calculator, PC, fax machine, etc.).
  • Ability to operate in a fast paced environment, sometimes requiring extended work hours

Qualification

  • B.S. in Engineering or Engineering related discipline
  • 0-2 years relevant experience. 
  • Experience in medical device development and/or manufacturing (regulated environment) preferred.
  • Working knowledge of FDA, ISO, and other regulations and standards preferred.
  • Working knowledge of Risk Analysis, Root Cause Analysis, Statistics and practical applications preferred.
  • ASQ Certifications (CQE, CRE, CQM, CSSBB) preferred.

Work From Home: No

Travel Percentage: Up to 25%

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.

Join our talent network

Joining our talent network will enhance your job search and application process. Whether you choose to apply or just leave your information, we look forward to staying connected to you.

Join Our Team