Staff Internal Quality Auditor

Work Flexibility: Remote or Hybrid or Onsite

Stryker is currently seeking a Staff Internal Quality Auditor to join our global Quality Management Systems team. This is a full-time remote role based in the Central or Eastern time zone, requiring 40% travel.  

As the Staff Internal Quality Auditor, you will be responsible for working collaboratively with key stakeholders from new and existing Global Quality and Operations (GQO) Stryker sites in the planning, execution and reporting of Internal Audits. You will quickly build strong relationships throughout Stryker’s global footprint. You must possess very strong written and oral communication skills and be able to report findings throughout all levels of the organization in a collaborative and fact-based manner that is conducive to building strong partnerships. A keen understanding of the highly regulated environment, great attention to detail, and the ability to make important decisions independently are requirements of the position. 

What you will do

• Lead Internal audits independently from planning, execution, closure, reporting, and post-audit follow-up 

• Plan and tailor the audit agenda and scope based on feedback and information received from the site being audited

• Interpret and provide guidance on applicable regulations such as FDA, ISO, MDD and Stryker policies  

• Assist in the coordination of Stryker Internal Audit program to ensure compliance to quality system requirements  

• Present audit results and correlating data to key stakeholders at the site location

• Escalate emerging trends of audit findings to identify areas for improvement 

• Interface with Site RAQA Heads, GQO Quality Management and International RAQA Management, where applicable

• Monitor observations from external and Corporate quality audits of Stryker sites

What you need

Required

• Bachelor’s degree

• Professional certification in Quality Auditing (i.e. Certified Lead Auditor)

• 4+ years medical device or FDA regulatory industry experience

• 2+ years Quality Audit experience (internal, external, and/or supplier)

• Comprehensive knowledge of FDA regulations, FDA QSR, ISO 13485:2016, Medical Device Directive Regulation (93/42EEC), and other national and international regulations

$77,200 - $123,700 USD salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.