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| 567548-QA Audit Leader WI 30 - 100k (J#13324) Education: Bachelors Degree Experience: 4 - 9 years Essential Functions (Responsibilities): As a senior member of the GEHC Audit staff the individual will manage a team of auditors who deliver GEHC's internal audit program. The jobholder will be accountable for the planning, execution and follow up of comprehensive reviews of GEHC's Global compliance status and risk profile against the GEHC Procedures and applicable national standards. The Principal Auditor will be an acknowledged expert in GxP compliance with an ability to manage develop and train audit team members to grow the overall competency within the organization. Key responsibilities include: Lead and manage a globally disparate and frequently traveling team of auditors, lead auditors and senior auditors. Developing their knowledge and skills to increase the senior audit pool within GEHC. Planning and follow up of a risk based audit program, assessing global compliance profile of GEHC. Proactively assess risk, plan and execute audit deliverables. Provide concise and clear recommendations and findings summaries for leadership. Ad hoc preparation for and support of regulatory inspection activities. Communicate audit results and recommendations to senior management. Drive business wide improvement plans according to findings. Interface with Senior Management and external regulatory agencies and partners during inspections, as necessary. As required provide a compliance knowledge expert resource to assists gap analyses and identify compliance risks, develop action plans, report progress and ensure closure. Qualifications/Requirements: Bachelor's degree with experience in regulated chemical, electronics or medical products industry OR minimum of 6 years experience in engineering, operations or quality supporting medical devices. Experience in QA in Medical Device & Pharmaceutical industry including internal or external quality system audits. Knowledge and depth of understanding of quality systems, especially 21CFR820, 21CFR 803, 21CFR 806, 21CFR 210, 21CFR 211, ISO 9001, ISO 13485 affecting medical devices Ability to travel globally to perform audits as needed, up to 35% travel with sometimes little notice Excellent verbal and written communication skills, interpersonal skills, strong analytical skills, and the ability to manage complexity Must be willing to take a drug test Must be willing to submit to a background investigation, including for example, verification of your past employment, criminal history, and educational background Must be legally authorized to work in the United States Must be willing to work out of an office located in Waukesha, Wisconsin Must submit application for employment through gecareers.com or COS if internal to be considered Desired: Experience as Agency auditor, especially with FDA. Global staff leadership experience. Strong process improvement mindset, passion for quality Strong strategic business perspective and systems thinking capability Certified auditor or lead auditor (i.e. ASQ certification) MS or higher in experience in regulated chemical, electronics or medical products industry Thorough understanding of GEHC procedures Knowledge and exposure to Lean Six Sigma tools Information regarding global National standards considered a plus Experience with high volume manufacturing and/or medical device design a plus | |||
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