Quality Analyst Lead - Bengaluru, India - Indegene

Description

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that's bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out

What if we told you that you can move to an exciting role in an entrepreneurial organization without the usual risks associated with it?

We understand that you are looking for growth in your career at this point and we would love for you to join us in our journey and grow with us. At Indegene, our roles come with the excitement you require at this stage of your career with the reliability you seek. We believe in creating leaders of tomorrow and mentor our leads to help them grow and nurture them as people managers and account managers.

We are a rapidly growing global organization and are scouting for the best talent for this phase of growth. With us, you are at the intersection of two of the most exciting industries of healthcare and technology. We offer global opportunities with fast-track careers while you work with a team that is fueled by purpose. The combination of this will lead to a truly differentiated experience for you.

If this excites you, then apply below.

QMS Lead

You will be responsible for:

Summary:

The QMS Lead plays a pivotal role in establishing and maintaining a robust Quality Management System (QMS) that ensures compliance with regulatory requirements and drives continuous quality improvement across the organization. This individual will champion the development, implementation, and ongoing effectiveness of the QMS, fostering a culture of quality throughout all departments.

Roles and Responsibilities:

• Lead the strategic development and implementation of the QMS from concept to execution, translating quality standards into actionable plans and operational procedures.
• Develop a comprehensive QMS deployment plan, including a detailed Work Breakdown Structure (WBS) to ensure efficient QMS setup.
• Conduct a thorough gap analysis, meticulously comparing product standards against current QMS requirements. Identify discrepancies and develop a roadmap for implementing necessary process engineering changes.
• Act as the primary liaison with Notified Bodies, facilitating smooth communication during QMS certification, review, and audit processes.
• Effectively manage transitions to the QMS due to external and internal changes by conducting thorough impact assessments and implementing appropriate actions.
• Oversee the collection, analysis, and reporting of data for critical Quality Key Performance Indicators (KPIs).
• Develop and manage comprehensive training programs for various aspects of the QMS, ensuring employee competence through a well-maintained competency matrix.
• Represent the QMS on various boards, committees, and working groups, such as the Change Control Board (CCB) and the Corrective Action and Preventive Action (CAPA) Review Board.
• Manage change control and ensure the document control system is maintained.
• Ensure good collaboration and maintain a constant communication with the client on the QMS activities
• Collaborate with design and process teams to provide expert support in risk assessment and mitigation strategies.
• Facilitate CAPA Review Board meetings at the site level and provide ongoing support to CAPA owners, ensuring timely and effective resolutions.
• Coordinate the creation, execution, and meticulous tracking of Management Review processes, fostering continuous improvement within the QMS.
• Facilitate internal and external audits, ensuring adherence to established processes and regulatory requirements.
• Partner with the Supplier Quality Management team to maintain a compliant and effective supplier network aligned with the overall QMS.
• Ensure good collaboration with suppliers and the follow up and closure of supplier quality issue
• Champion clear communication and education on QMS regulations, policies, and strategies across all organizational levels.
• Hold ultimate approval authority for quality-related events, complaints, CAPAs, and Change Controls.
• Implement and manage Incoming Goods Inspection procedures, along with overseeing batch and device release documentation.
• Prepare for, actively monitor, and provide comprehensive support during internal and external audits and inspections.
• Actively collect and analyze quality KPIs, ensuring data-driven decision making. Regularly review and update Standard Operating Procedures (SOPs) and Work Instructions (WIs), incorporating necessary training updates.
• Conduct thorough investigations, implement root cause analysis, and actively support risk management activities to minimize potential quality issues.

Your impact:

About you:

Skills:

• Hands-on experience in developing and maintaining clear, concise Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Proven track record of successfully leading QMS implementations and delivering effective training programs.
• In-depth expertise in process engineering, QMS structure development, and comprehensive documentation practices.
• Strong working knowledge of design documentation for all types of medical devices, including standalone software.
• Deep understanding of ISO 13485:2016, 21 CFR 820, and risk management principles outlined in ISO 14971.
• Familiarity with medical device regulations (21 CFR, MDD/EU MDR, MDSAP) and relevant global quality standards.
• Proficiency in LEAN concepts and methodologies for continuous improvement.
• Strong proficiency in MS Office Suite.
• Excellent communication, technical documentation, and mentoring skills.
• Excellent organizational, verbal, written communication and time management skills that are action oriented and customer focused.

Must have:

Qualifications:

• Bachelor's or Master's degree in Engineering (Electrical, Mechanical, Medical Technology, or a related field)
• Minimum of 6 years of experience in Medical Devices Quality Assurance/Research & Development (QA/R&D), with at least 2 years of demonstrated leadership experience in managing projects and teams.
• Certified Lead Auditor in ISO 13485 from a reputable organization (e.g., BSI, TÜV).

Nice to have:

Additional Responsibilities:

• Staying abreast of evolving regulatory requirements and industry best practices for Quality Management Systems.
• Actively seeking opportunities to streamline processes and enhance the overall effectiveness of the QMS.
• Fostering a culture of quality within the organization by promoting employee engagement and ownership of quality initiatives.

EQUAL OPPORTUNITY

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate's merit and qualification.

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.