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Staff Auditor - Corporate Audit in Portage, MI at Stryker Corporation

Date Posted: 4/4/2019

Job Snapshot

Job Description

Who we want

Do you have a passion and a drive for quality? Are you looking to be part of a motivated, highly visible team with a leader in the medical technology industry? If so becoming a Staff Auditor - Corporate Audit at Stryker will give you just that!!

Our top candidates will possess very strong written and oral communication skills and be able to report findings throughout the organization in a manner that is collaborative and fact-based, while simultaneously supporting the needs of our site-based customers. In addition, the best candidates will possess a keen understanding of a highly regulated environment, great attention to detail and the ability to make important decisions independently. Lastly, the ability to quickly build strong relationships throughout the global organization is a must.

What you will do

In this position, you will be responsible for working collaboratively with key stakeholders from Stryker sites in the planning, execution and reporting of corporate audits. You will also be responsible for leading acquisition assessments for any new Stryker sites acquired through Mergers/Acquisitions.

  • Lead Corporate audits independently from planning, execution, closure, reporting, and post-audit follow-up
  • Lead Acquisition Assessments of the newly acquired Stryker sites through Mergers/Acquisitions (M&A)
  • Plan, tailor the audit agenda and scope based on processes performed at the auditee site
  • Partner with Integration Team(s) to support development of detailed Integration Action Plan(s)
  • Interpret applicable regulations such as FDA, ISO, MDD and Stryker policies 
  • Lead/Assist in the coordination of Stryker Corporate Quality Audit program to ensure compliance to quality system requirements 
  • Present audit results and correlating data to key stakeholders within Stryker
  • Perform trend analysis of audit findings to identify areas for improvement 
  • Interface with Division RAQA Heads, GQO Quality Management and International RAQA Management to assure alignment to Stryker Global Quality Management System 
  • Monitor external quality audits of Stryker sites.  Provide corporate support to the site and communicate areas of interest to appropriate Global Process Owners.
  • Train and mentor fellow auditors both within the Corporate Quality Audit Program but also across Stryker 

What you need

  • B.S. in Science or Engineering (Quality Engineering experience preferred)
  • Professional certification in Quality Auditing (i.e. Certified Lead Auditor) strongly preferred
  • Minimum of 5 years medical device or regulated industry experience
  • Minimum of 2 years Quality Audit experience (internal, external, and/or supplier)
  • Comprehensive knowledge of FDA regulations, ISO 13485:2016, Medical Device Directive Regulation (93/42EEC), and other national and international regulations.
  • Solid knowledge of manufacturing processes, statistical techniques, validation, sterilization, environmental controls and basic Regulatory requirements for medical devices

Work From Home: No

Travel Percentage: Up to 50%

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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