Senior Quality Assurance Specialist

MiniMed; Hyderabad; On-site; INR 1,500,000 - 2,200,000; Full time

Job summary

MiniMed is seeking a Senior Quality Assurance Specialist to maintain and enhance our Quality Management System (QMS) to ensure regulatory compliance and product quality across the diabetes portfolio. You will lead investigations, CAPAs, audits, and continuous improvement initiatives in collaboration with cross-functional teams.

The role requires 5–7 years in QA within a regulated environment, including 2–3 years in medical devices, with strong knowledge of ISO 13485 and risk management.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Biomedical Engineering, or related discipline.
• 5-7 years of Quality Assurance experience in a regulated industry.
• Minimum 2-3 years in Medical Devices industry.
• Experience with ISO 13485 compliant QMS.

Responsibilities

• Maintain and improve the Quality Management System in accordance with regulations and standards.
• Lead investigations related to non-conformances, deviations, and quality issues.
• Plan, coordinate, and participate in internal audits and support external audits.
• Support supplier qualification, evaluation, and monitoring activities.
• Review changes for quality and regulatory impact and ensure risk assessments.
• Participate in risk management throughout the product lifecycle.
• Provide guidance and training on quality system requirements.
• Develop and monitor key quality performance indicators.

Skills

Quality Assurance

ISO 13485

CAPA investigations

Audits & regulatory compliance

Root cause analysis

Risk management

Stakeholder collaboration

Education

Bachelor’s degree in Life Sciences/Pharmacy/Biotechnology

Master’s degree in a relevant field

ASQ CQA certification

Tools

Quality Management System (QMS) software

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

Physical Job Requirements

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.

Benefits & Compensation

MiniMed offers a competitive salary and flexible benefits package

At MiniMed, we put people first. A commitment to our employees lives at the core of our values: We recognize their contributions. They share in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life.

About MiniMed

We want to make every day a better day for people living with diabetes. Our team of creative innovators around the globe share a passion for finding the simplest solutions to the problems that people with diabetes face on a daily basis. For more than 40 years, we’ve been redefining what’s possible, from intelligent dosing systems designed for real life to predictive insights that stay a step ahead, and we’re dedicated to continuing to support our customers through every step of their journey — meeting them where and how they need it.