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Sr Lead Quality Auditor, Information Technology in Allendale, NJ at Stryker Corporation

Date Posted: 1/19/2019

Job Snapshot

Job Description

Stryker's Information Systems (IS) Senior Lead Auditor supports all areas of the IS Quality Management System (QMS) internal audit function including IS internal auditor of QMS process areas and IS vendor/suppliers, support of IS compliance audit activities, and support of external audits for business functions (e.g., FDA, MDSAP, notified body) in efforts to ensure regulatory requirements are met.

Essential Duties & Responsibilities include:

  • Lead and/or participate in coordination of the audit, review of process area documented procedures to determine adherence to ISO standards and leading industry practices, participation as directed by the lead auditors.
  • Prepare audit reports and track audit findings/non-conformances including metrics and monthly reporting.
  • Support external audits (e.g., FDA and Notified Bodies) by collaborating with the audit facilitator/host and coordinating collection of IS documentation required per audit scope by working with the subject matter experts within IS.
  • Update the IS Compliance & Audit tracking tool to include audits and corresponding findings and periodically (e.g., quarterly) report on overall status.
  • Review and track metrics of the ITGC monthly/quarterly compliance reviews.
  • Work with control owners in refinement of procedures associated to their controls.
  • Keep current on emerging IS risks, emerging industry and governing body trends, and IS relevant topics.
  • May also support the SOX audit lead in coordination of the SOX ITGC audits (internal and external) as well as other IT operational audits. This includes audit facilitation, request list coordination, and audit finding/management action plan tracking.

Education & Special Trainings:

  • Bachelors degree from an accredited institution required.
  • Auditor qualifications and certifications such as Certified Quality Auditor (CQA) or ISO Lead Auditor are a plus.

Minimum Qualifications & Experience:

  • 3+ years experience working in a regulated industry (eg. Life Science, Medical Device, Finance) is required.
  • Auditing experience, including planning/executing/reporting, and hosting/facilitating required.

  • Thorough understanding of QMS principles required.

  • Working knowledge of industry standard frameworks (e.g., ISO 9001/27001/20000, COBIT, COSO) required.

  • Understanding of 21 CFR 820 required.

  • IT General Computer Control principles and practices preferred.

  • Understanding of SOX controls and compliance principles is a plus.

  • Experience with ERP systems (e.g., Oracle, JD Edwards, iSeries, SAP) desired.

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.

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