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Job Description

Position Description

The Senior Clinical Quality Manager is responsible for assuring that clinical personnel across Neuromodulation are operating within U.S. and international regulatory requirements, Medtronic standards, and facilitating continuous improvements to processes and procedures.
The Senior Clinical Quality Manager manages coordination of the activities of the clinical quality team, with responsibility for results in terms of costs, methods and employees.  Results are accomplished generally through experienced exempt employees who exercise significant latitude and independence in their assignments.  The Senior Clinical Quality Manager functions as an advisor to the team regarding tasks, projects, and operations, and may become actively involved in daily operations when required to meet schedules, or to resolve complex problems. The Senior Clinical Quality Manager has frequent contacts with internal personnel at various management levels concerning operations or scheduling of specific phases of projects. In addition, this position has contacts with other Neuromodulation business and Corporate partners.

Position Responsibilities
• Provides oversight and development of Clinical Quality Specialist team members, including:  directing workflow and responsibilities, evaluating job performance and providing performance reviews.
• Provides oversight and strategic direction of the Compliance Assurance Program which entails audits and assessments of studies, clinical investigational sites and service providers; Ensures proper documentation of audit observations and tracking of corrective and preventive actions.
• Provides direct support and/or oversight to Regulatory inspection activities and is the point of contact for internal business or Corporate Audits.
• Acts as an advisor on clinical quality assurance issues such as patient informed consent forms, device accountability, clinical investigational plans and other study documents.•Implements policies and procedures aligned with relevant global regulations and standards; may work with cross-functional teams to ensure policies and procedures are aligned across the organization.
• Works with study personnel and management on issues that require escalation, including the escalation of issues to the business unit as applicable.

Job Requirements

Basic Qualifications
• Bachelor’s degree in engineering, medical, business or life science.
• Ten years experience directly supporting clinical research within a regulated environment, or a quality systems in a medical device environment.
• Minimum 5 years of exempt level supervisory experience.
• Working experience with  FDA and international regulations GCPs (pharmaceutical and/or device).

Desired/Preferred Qualifications
• Experience in Quality Systems (QSR 820 and ISO 13485) working environment.
Certified Lead Auditor.
• High attention to detail and accuracy.
• Strong leadership skills along with strong influence management skills.
• Able to manage multiple tasks.