Establish and maintain the Quality Management System (QMS) in alignment with global Medtronic standards and ISO 13485.
Oversee quality functions such as CAPA, change control, complaint handling, supplier quality, validation, and process audits.
Drive continuous improvement initiatives across all manufacturing and R&D sites.
Ensure product design and production meet regulatory and safety requirements.
Lead regulatory strategy for new product submissions, registrations, renewals, and post-market surveillance.
Liaise with regulatory authorities (CDSCO, FDA, EMA, TGA, etc.) and ensure successful audits, inspections, and submissions.
Review and approve labeling, packaging, and technical documentation for compliance.
Monitor and interpret global regulatory changes and assess their impact on Medtronic operations.
Ensure all internal and external audits are completed successfully.
Serve as the Management Representative for quality and compliance for the assigned region.
Maintain compliance with corporate, local, and international standards (GMP, ISO, MDR, MDSAP, etc.).
Oversee risk management processes and ensure product traceability.
Develop and implement long-term quality and regulatory strategies aligned with corporate goals.
Represent the Q&R function in executive meetings and decision-making forums.
Drive organizational change toward a โRight First Timeโ culture.
Lead and mentor teams of quality engineers, regulatory specialists, and auditors.
Collaborate with R&D, Operations, Supply Chain, and Clinical Affairs to ensure end-to-end compliance.
Build talent pipelines, provide coaching, and foster professional development in the Q&R team.
Competitive base salary โ typically at the top end of the medical device industry.
Annual performance bonus based on company and individual performance.
Stock purchase plan (ESPP) โ eligible employees can buy Medtronic shares at a discounted rate.
Provident Fund (PF) & Gratuity โ statutory retirement savings benefits.
Annual pay revision linked to performance ratings.
Comprehensive health insurance covering employee, spouse, children, and dependent parents.
Coverage includes hospitalization, maternity, dental, and optical care.
Life insurance and accidental death coverage (typically 3โ5x annual salary).
Employee Wellness Program (Healthy You @ Medtronic) offering fitness, nutrition, and mental health resources.
On-site medical support or telemedicine consultation access in most major offices.
Flexible / Hybrid Work Policy โ many director-level employees have flexible scheduling or partial remote work.
Paid time off (PTO):
25โ30 days of annual leave (depending on location and tenure).
Paid sick leave and casual leave.
Maternity / paternity leave in line with or exceeding local regulations.
Company holidays and optional โwell-being daysโ encouraged.
Access to Medtronic University โ an internal platform for global leadership and technical training.
Leadership development programs tailored for director and senior management roles.
Tuition reimbursement or sponsorship for higher education, certifications, or Six Sigma / RAC / PMP courses.
Global mobility opportunities through short-term or long-term international assignments.
Clear career advancement path toward Senior Director or Vice President roles.
Recognition through Medtronic Excellence Awards and innovation programs.
Opportunity to lead global quality and regulatory initiatives.
Exposure to cross-functional teams across R&D, manufacturing, operations, and compliance.
Travel allowance for business and leadership meetings.
Meal and transport reimbursement in some locations.
Employee assistance program (EAP) for mental health, legal, and financial counseling.
Diversity, Equity & Inclusion (DEI) initiatives and employee resource groups.
Access to volunteer time-off (VTO) โ employees can take paid days to engage in community service.