Job Posting: QMS Research Associate – Adiuvo Diagnostics Pvt. Ltd.
Summary:
Adiuvo Diagnostics, a rapidly growing MedTech innovator, is seeking a highly motivated and detail-oriented QMS Research Associate to join our team in Chennai. In this role, you will play a crucial part in supporting the implementation, maintenance, and continuous improvement of our Quality Management System (QMS), ensuring compliance with ISO 13485, USFDA, CDSCO, and other relevant regulatory standards. This is an excellent opportunity for a driven individual to gain hands-on experience in a dynamic, regulated environment and contribute to the advancement of innovative medical diagnostic technologies.
About Adiuvo Diagnostics Pvt. Ltd.
Adiuvo Diagnostics is at the forefront of developing advanced, non-invasive medical diagnostic technologies that empower clinicians to deliver improved patient care. We are committed to innovation and excellence, and operate within a highly regulated environment, making the role of Quality Management professionals paramount to our success. We are seeking a passionate and skilled individual to contribute to our mission of transforming healthcare through cutting-edge technology.
Role: QMS Research Associate (Full-Time, On-Site)
Location: Chennai, Tamil Nadu
Reports To: CEO / COO / Head of Production
Key Responsibilities:
As a QMS Research Associate, you will be responsible for a wide range of activities related to the development, implementation, and maintenance of our QMS. Your responsibilities will include:
1. QMS Documentation & Records Management:
- Developing, reviewing, and updating Standard Operating Procedures (SOPs), Work Instructions, Forms, and Quality Manuals.
- Maintaining meticulous version control of all QMS documents using a Document Control System.
- Managing Corrective and Preventive Action (CAPA) files, training logs, and other essential internal quality documentation.
2. Compliance & Regulatory Support:
- Ensuring strict alignment of QMS processes with ISO 13485, ISO 14971, USFDA (21 CFR Part 820), and CDSCO regulations.
- Assisting in the preparation and execution of regulatory audits and supporting the creation of submission documentation.
- Staying abreast of evolving regulatory norms and proactively updating QMS processes to maintain compliance.
3. Internal Audits & CAPA Management:
- Supporting the planning, execution, and follow-up of internal audits across all departments.
- Coordinating the investigation, documentation, and resolution of Non-Conformances (NCRs), CAPAs, and deviations.
- Ensuring the timely and effective implementation of corrective and preventive actions.
4. Quality Data Analysis & Metrics Tracking:
- Tracking and reporting key performance indicators (KPIs) related to quality performance, including NCR trends, calibration schedules, audit findings, and training compliance.
- Preparing comprehensive reports for management review meetings, highlighting areas for improvement and opportunities for optimization.
5. Training & Cross-Functional Coordination:
- Managing and delivering QMS-focused training sessions for employees across various departments.
- Collaborating effectively with cross-functional teams, including R&D, Manufacturing, Operations, and Quality Assurance, to ensure seamless integration of QMS processes.
- Providing guidance and support to new hires on QMS procedures and requirements.
6. Risk Management Support:
- Assisting in the maintenance and updating of Risk Management Files (RMF) in accordance with ISO 14971.
- Supporting Failure Mode and Effects Analysis (FMEA) activities and hazard identification processes.
- Participating in design and development risk assessments to proactively identify and mitigate potential risks.
Required Qualifications & Skills:
- Bachelor’s or Master’s degree in Biotechnology, Biomedical Engineering, Microbiology, Life Sciences, or a related field.
- 1-3 years of relevant experience in QMS, Quality Assurance, or Regulatory roles, preferably within the medical device industry.
- Solid understanding of ISO 13485, ISO 14971, USFDA (21 CFR Part 820), and CDSCO regulations.
- Exceptional documentation, organization, and communication skills (both written and verbal).
- Proven ability to work effectively in cross-functional teams and adhere to structured processes.
- Strong analytical and problem-solving skills.
Preferred Skills (Added Advantage):
- Prior experience conducting internal audits in accordance with ISO 13485.
- Exposure to design and development workflows in a regulated environment.
- Familiarity with QMS software and document control systems.
- Understanding of Good Manufacturing Practices (GMP) and medical device manufacturing processes.
Benefits of Working at Adiuvo Diagnostics:
- Opportunity to contribute to the development of innovative MedTech solutions with a direct impact on patient care.
- Exposure to global regulatory frameworks, including USFDA and ISO 13485.
- Hands-on experience with audits and comprehensive QMS systems.
- A stimulating learning environment with significant opportunities for professional growth and development.
- Collaborative and supportive work environment with cross-functional teams.
- Competitive salary and benefits package.