Senior Auditor

Senior Auditor

Job Number 1470974
Business GE Healthcare
Business Segment Healthcare Quality
Posted Position Title Senior Auditor
Career Level Experienced
Function Quality
Function Segment Internal Audit
Location United States
U.S. State, China or Canada Provinces Wisconsin
City Waukesha
Postal Code 53188-1696
Relocation Assistance Yes
Role Summary/Purpose As a member of the GE Healthcare's (GEHC's) Global Quality Compliance (GQC) audit staff, the Sr. Auditor will work with a team of auditors to deliver GEHC's Quality, Regulatory, Medical (QRM) audit program. He/she will plan, execute and follow-up on comprehensive reviews of GEHC's global compliance status against the GEHC procedures and applicable national standards, and report compliance concerns, and recommended improvements, to quality management and business leadership.
Essential Responsibilities .Conduct reviews, perform audits and document findings for complex and unusual businesses
.Provide follow up activities to ensure compliance with regulations and conformance with written and approved procedures
.Provide direction on root cause, proactively assess risk, plan and execute audit deliverables
.Communicate audit results and recommendations
.Provide leadership in driving improvement efforts
.Interface with senior mgmt & external regulatory agencies during inspections, audits, investigations & report outs
.Lead local QRM personnel to identify compliance risk, develop action plans, report progress, and ensure closure
.May provide specialist support during external audits or inspections or conduct technical/ombuds investigations in response to compliance concerns in the QARA area
.May provide support to improvement or remediation QRM projects
.Provide Subject Matter Expertise of quality systems, including 21CFR820, 21CFR 803, 21CFR 806, 21CFR 210, 21CFR 211, ISO 9001, ISO 13485 affecting medical device
Qualifications/Requirements 1.Bachelor's degree with minimum 6 years experience in engineering, operations, quality assurance and / or regulatory affairs (including a minimum of 3 years experience in quality assurance or regulatory affairs) in a regulated chemical, electronics or medical products industry -- OR -- minimum of 12 years experience in engineering, operations, quality assurance and / or regulatory affairs (including a minimum of 3 years experience in quality assurance or regulatory affairs) in a regulated chemical, electronics or medical products industry
2.Experience with internal or external quality system audits
3.Knowledge and understanding of quality systems, such as QSR/ISO 9001/ISO 13485 affecting medical devices
4.Ability to travel globally to perform audits as needed, up to 50% travel with sometimes little notice
5.Prior experience using spreadsheet and presentation software
6.Strong ability to communicate effectively in English, including the ability to synthesize complex issues into clear & concise messages
Additional Eligibility Qualifications GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.
Desired Characteristics 1.Certified auditor or lead auditor (i.e. ASQ certification)
2.Experience with high volume manufacturing and/or medical device design
3.Experience in QA in Medical Device and / or Pharmaceutical industry
4.Knowledge of global national standards
5.Strong process improvement mindset, passion for quality
6.Strong strategic business perspective and systems thinking capability
7.Excellent interpersonal skills
8.Strong analytical skills
9.Experience applying Lean Six Sigma tools to drive process improvements
10.Understanding of GEHC procedures