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| 576719-QA Manager-Regulatory WI 30 - 100k (J#13321) Education: Bachelors Degree Experience: 4 - 9 years Essential Functions (Responsibilities): The central team QA Manager role will develop and oversee compliant global business processes related to post-market product surveillance and complaints, product safety regulatory reporting, and corrective and preventive actions to assure safe and effective products in the installed base. Responsibilities include: o Develop and issue business procedures that meet applicable global regulations in the areas of post-market complaint handling, reporting, CAPA and field actions o Develop and drive improvements to overall Quality Management System documentation to provide clear flow down of regulations in related post-market areas o Educate, train, advise and coach business leaders and QA/RA practitioners on the related regulations, procedures and work instructions o Audit business units for compliance and consistency, and track/address trends observed that could lead to non-compliance, or risk to patient/user safety o Interface with senior leaders and site leader partners during inspections, audits, investigations, and report-outs as necessary o Collect, summarize and evaluate compliance performance metrics to identify program weaknesses and rive improvements in procedures or oversight Qualifications/Requirements: 1. Bachelor's degree in scientific or technology discipline, or engineering, or high school diploma/GED plus 8 years working experience and understanding of Quality or Regulatory Assurance 2. Minimum 5 years experience in the medical device or drug industry 3. Minimum 3 years supervisory/management experience, or demonstrated ability to lead cross- functional, cross-business teams 4. Subject matter expert in post-market surveillance and regulatory reporting, 5. Demonstrated knowledge of Quality Management Systems (demonstrated experience with ISO, GxP, FDA and other key regulatory bodies) and experience with new product and post-market product processes 6. Ability to communicate using English 7. Must be 18 years of age or older 8. Must be willing to take a drug test as part of the selection process 9. Must be willing to submit to a background investigation, including for example, verification of your past employment, criminal history, and educational background 10. For US, must have unrestricted legal authorization to work in the United States 11. Must be willing to work in Waukesha, WI. Desired: 1. Master's degree in scientific or technology discipline, or engineering 2. ASQ Certification as Quality Manager (CQM), Operations Excellence (OE), or other related discipline 3. Demonstrated compliance program management/leadership experience. Able to prioritize, plan, delegate and evaluate deliverables to established strategic goals 4. Demonstrated process/lean skill to drive project execution with discipline 5. Demonstrated collaboration, negotiation & conflict resolution skills. Ability to build a connection with the team through personal involvement & trust & providing feedback & coaching to help develop others 6. Visibly demonstrates comfort & efficacy in presenting to and in communicating with top organizational leadership & internal & external customers, responding in a professional manner 7. Familiar with classic quality tools & experienced in applying them to monitor function performance 8. Global regulatory experience & demonstrated experience interfacing with FDA 9. Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures) 10. Integrity: Adhering to high ethical, moral & personal values in decisions, communications & actions 11. Prior experience using word processing, spreadsheet, and presentation software. | |||
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