Senior Quality Systems Spec

MiniMed Group; Hyderabad; On-site; INR 900,000 - 1,300,000; Full time

Job summary

MiniMed Group is hiring a Senior Quality Assurance Specialist to maintain and enhance the QMS, lead CAPA investigations, and drive regulatory readiness. The role covers distribution, supplier quality oversight, post-market surveillance, and change control to ensure compliance with ISO 13485 and MDR requirements.

The successful candidate will collaborate with cross-functional teams, manage audits, and promote continuous improvement across the organization.

Qualifications

• Degree qualifications as listed: Life Sciences/ Pharmacy/ Biotechnology/ Biomedical Engineering; plus preferred master's degree.
• ASQ CQA or equivalent certification preferred.
• Quality systems experience in a regulated environment (ISO 13485).

Responsibilities

• Maintain and continuously improve the Quality Management System (QMS) per regulations and standards.
• Lead investigations for non-conformances, deviations, complaints, and CAPA activities.
• Plan and participate in internal audits; support external audits by authorities and customers.
• Support supplier qualification, evaluation, audits, and quality reviews.
• Review changes for quality/regulatory impact and ensure risk assessments are completed.
• Participate in risk management throughout product lifecycle and mitigate risks.
• Provide training on quality system requirements and promote a culture of continuous improvement.
• Develop and monitor quality metrics; present data to management; drive CAPA closure.

Education

Bachelor's degree in Life Sciences/ Pharmacy/ Biotechnology/ Biomedical Engineering

Master's degree in a relevant field

ASQ Certified Quality Auditor (CQA) or equivalent

Strong influencing & stakeholder management

Excellent verbal & written communication

Critical thinking & problem solving

Ability to manage multiple priorities

Job description

## Senior Quality Systems SpecApply: Flexible: Hyderabad, Telangana, India: Full time: Posted Today: R-802014At 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