Senior Quality Assurance Specialist

USA-MiniMed Distribution Corp. 1018; Hyderabad; On-site; INR 1,500,000 - 2,700,000; Full time

Job summary

MiniMed's Global Diabetes Capability Center in Pune is expanding to support patients worldwide. The Senior Quality Assurance Specialist will maintain and improve the QMS to ensure compliance with ISO 13485, MDR, and regional requirements, while collaborating with cross-functional teams in distribution, supplier management, and post-market surveillance.

You will lead quality investigations, CAPAs, audits, and continuous improvement initiatives, drive risk-based decision making, and mentor staff

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Biomedical Engineering, or related discipline.
• Master's degree in a relevant scientific or technical field (preferred).
• ASQ CQA or equivalent certification preferred.

Responsibilities

• Maintain and continuously improve the Quality Management System (QMS) in line with ISO 13485, MDR, and regional requirements.
• Lead investigations related to non-conformances and CAPA activities from initiation to verification.
• Plan, coordinate, and participate in internal audits; support external audits by regulatory bodies and customers.
• Support supplier qualification, evaluation, and monitoring; manage supplier-related quality issues and corrective actions.
• Review changes for quality and regulatory impact; ensure risk assessments and approvals are completed.
• Participate in risk management throughout the product lifecycle; support risk assessments for processes, suppliers, products, and events.
• Provide guidance and training on quality system requirements; promote a culture of quality and continuous improvement.
• Develop and monitor key quality performance indicators and present data to management.

Skills

Quality Assurance

ISO 13485

CAPA

Audits

Risk Management

QMS

Regulatory Compliance

Training

Quality Metrics

Education

Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Biomedical Engineering, or related discipline

Master's degree in a relevant field (preferred)

ASQ Certified Quality Auditor (CQA) or equivalent (preferred)

Job description

At MiniMed, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world.

About the Role

A Day in the Life

Our Global Diabetes Capability Center in Pune is expanding to serve more people living with diabetes globally. Our state-of-the-art facility is dedicated to transforming diabetes management through innovative solutions and Technologies that reduce the burden of living with diabetes.

This position is an exciting opportunity to work with Minimed's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.

#BetterDaysStartNow

Position Summary

The Senior Quality Assurance Specialist is responsible for maintaining and improving the Quality Management System (QMS) to ensure compliance with applicable regulatory requirements, international standards, and company procedures. This role supports quality operations across distribution, supplier management, post-market surveillance, and quality system processes. The successful candidate will serve as a key quality representative, leading quality investigations, CAPAs, audits, compliance activities, and continuous improvement initiatives while partnering with cross-functional teams to ensure quality and regulatory compliance.

Key Responsibilities

• Quality Management System (QMS)
  • Maintain and continuously improve the Quality Management System in accordance with applicable regulations and standards.
  • Ensure compliance with ISO 13485, MDR, and other applicable regional requirements.
• Non-Conformance and CAPA Management
  • Lead investigations related to non-conformances, deviations, complaints, and quality issues.
  • Facilitate root cause analysis using appropriate quality tools.
  • Manage Corrective and Preventive Action (CAPA) activities from initiation through effectiveness verification.
• Audit Management
  • Plan, coordinate, and participate in internal audits.
  • Support external audits by certification bodies, notified bodies, regulatory agencies, and customers.
• Supplier Quality Oversight
  • Support supplier qualification, evaluation, and monitoring activities.
  • Participate in supplier audits and quality reviews.
  • Manage supplier-related quality issues and corrective actions.
• Change Control
  • Review and assess proposed changes for quality and regulatory impact.
  • Ensure appropriate risk assessments and approvals are completed.
  • Monitor change implementation and effectiveness.
• Risk Management
  • Participate in risk management activities throughout the product lifecycle.
  • Support risk assessments associated with processes, suppliers, products, and quality events.
  • Ensure quality risks are identified, documented, and mitigated.
• Training and Compliance
  • Provide guidance to employees on quality system requirements.
  • Support compliance training and awareness programs.
  • Promote a culture of quality and continuous improvement throughout the organization.
• Quality Metrics and Continuous Improvement
  • Develop and monitor key quality performance indicators.
  • Analyse quality trends and identify opportunities for improvement.
  • Lead or participate in continuous improvement initiatives.
  • Present quality performance data to management.
• Regulatory and Inspection Readiness
  • Support health authority inspections and certification audits.
  • Assist in preparation of audit responses and quality records.
  • Ensure ongoing inspection readiness across the business.

Education

• Required
  • Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Biomedical Engineering, or related discipline.
• Preferred
  • Master's degree in a relevant scientific or technical field.
  • ASQ Certified Quality Auditor (CQA) or equivalent certification.

Experience

• Required
  • 5-7 years of Quality Assurance experience in a regulated industry.
  • Minimum 2-3 years working within Medical Devices Industry.
  • Experience working with Quality Management Systems compliant with ISO 13485.

Behavioural Competencies

• Strong influencing skills
• Excellent verbal and written communication
• Strong stakeholder management
• Critical thinking and problem-solving
• Ability to manage multiple priorities in a fast-paced environment

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benef