Medtronic

Director, Quality and Regulatory

Medtronic

full-time

Posted on:

Origin:  • 🇮🇳 India

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Job Level

Lead

About the role

  • Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
  • Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
  • Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
  • Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
  • Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
  • Co-ordinates legal requests in support of government investigations or litigations.
  • Ensures the quality assurance programs and policies are maintained and modified regularly.
  • Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
  • Manages, mentors and develops staff, including defining performance goals, conducting performance reviews and 1:1s, and directing workforce and staffing plans.

Requirements

  • Management and supervisory experience managing one or more employees; typically six or more direct reports
  • Experience leading departments or small units with multiple teams led by managers/supervisors
  • Ability to provide technical and thought leadership and perform work without appreciable direction
  • Experience developing strategy for a department or business area and making large business decisions
  • Budget or P&L accountability experience
  • Experience driving innovation and improving department processes, systems, products or services
  • Experience communicating and briefing senior or executive leadership
  • Experience directing and leading a department, including authorizing hiring, firing, promotions and rewards
  • Mastery level knowledge in a specific technical or professional discipline with broad understanding of other areas
  • Experience with quality programs, systems, processes and procedures ensuring compliance with internal and external standards
  • Expertise in interpreting policies, regulatory and governmental regulations, and internal regulations
  • Experience in audit and inspection preparation, resolution of findings, and liaising with auditors/inspectors
  • Experience preparing Corrective and Preventative Actions (CAPA) and related documentation
  • Experience coordinating legal requests in support of government investigations or litigations
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