Clinical Quality Manager Medtronic
Overview
Clinical Quality Manager leads quality systems and compliance across Surgical organization. This role drives quality excellence in regulated environment. Opportunity to shape healthcare future while building impactful career.
What You'll Do14
- 1Lead and develop high performing team through clear prioritization coaching and capability building to deliver quality outcomes at scale
- 2Assess accuracy and quality of data submitted to outside the CMAH team including regulatory agencies
- 3Drive QMS/QDR forums and reporting by consolidating quality data preparing review materials and facilitating leadership discussions
- 4Proactively identify and manage risks and issues by assessing trends surfacing gaps and escalating concerns in a clear decision ready manner
- 5Own and improve clinical quality processes and standards by identifying opportunities to increase efficiency consistency and inspection readiness
- 6Partner cross functionally with clinical regulatory and quality teams to resolve findings address deficiencies and ensure alignment on expectations
- 7Create and maintain clinical quality assurance databases reports and files
- 8Perform quality reviews and track corrective and preventive actions until closure
- 9Act as advisor on clinical quality assurance protocols amendments and biological licensing agreements
- 10Audit operating systems processes and procedures
- 11Support risk management operations including ongoing review of literature and compilation and interpretation of safety data to support product strategies
- 12Plan and prepare report drafts for products compliance statements audit certifications and safety issues for regulatory submission
- 13Use six sigma methodology
- 14Provide training on GCP and current regulations for those undertaking clinical studies
Requirements9
- 1Minimum Bachelor’s degree required
- 2Minimum of 5 years of relevant experience or advanced degree with minimum of 3 years relevant experience
- 3Knowledge of Medtronic systems
- 4Understanding of the clinical Quality and Regulatory environments
- 5Experience in the Medical Device Industry
- 6Physical mobility required for office duties
- 7Ability to interact with computers and communicate with peers and coworkers
- 8Unrestricted U.S. work authorization for principal level roles
- 9Candidates meeting all stated qualifications
Salary Insight
Salary not disclosed in listing
Location
Required Skills
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