ISO 13485 / ISO 17025 / ISO 15189 Quality Systems Specialist
Company: EMPOWERING ASSURANCE SYSTEMS PVT LTD
Location: Chennai, Tamil Nadu
Work Mode: Chennai-based / Travel across India & overseas as required
WFH: Available for Empanel Auditor & Tutor engagements
Employment Type: Full-time / Empanel
Vacancies: 5
Experience: Freshers & Experienced
Qualification: Any Degree
Salary: ₹20,000 – ₹50,000 per month, based on experience and competency
About the Role
Empowering Assurance Systems Pvt Ltd is looking for enthusiastic and career-oriented professionals to support ISO certification, auditing, consultancy, documentation, implementation and training activities in the medical device, testing, calibration and medical laboratory sectors.
Candidates with knowledge or experience in ISO 13485, ISO/IEC 17025 and ISO 15189 are encouraged to apply.
Freshers with relevant ISO qualifications and experienced professionals are welcome.
Key Responsibilities
- Support internal, supplier, gap assessment and certification audits.
- Assist Lead Auditors during Stage 1, Stage 2, surveillance and recertification audits.
- Prepare audit plans, checklists, sampling plans and audit reports.
- Conduct compliance reviews, interviews and objective evidence collection.
- Support assessment of medical device quality systems, risk management, traceability, validation and supplier controls.
- Support laboratory quality assessments including calibration, measurement traceability, method validation and equipment controls.
- Support medical laboratory quality assessments covering sample handling, competency and quality assurance.
- Prepare and review nonconformity reports, CAPA and corrective actions.
- Develop and maintain manuals, procedures, SOPs, forms and quality records.
- Support medical device documentation, laboratory documentation and accreditation requirements.
- Assist clients with ISO implementation, certification and NABL accreditation readiness.
- Conduct awareness and internal auditor training as a Tutor.
- Coordinate audits, client communication, documentation and follow-up activities.
Required Skills
- Knowledge of quality management systems and ISO requirements.
- Understanding of audit planning, sampling, evidence collection and reporting.
- Knowledge of nonconformity, root cause analysis and CAPA.
- Understanding of risk management, validation and verification.
- Good documentation and technical report-writing skills.
- Good communication and client coordination skills.
- Proficiency in MS Word, Excel and PowerPoint.
- Willingness to travel across India and overseas.
Preferred Skills
- Medical device quality systems and ISO 13485.
- Laboratory quality systems and ISO/IEC 17025.
- Medical laboratory quality systems and ISO 15189.
- NABL accreditation experience.
- Knowledge of regulatory compliance and healthcare quality systems.
- Experience with certification bodies, laboratories, consultancy or training organisations.
Preferred Qualifications
- ISO 13485 Internal Auditor / Lead Auditor
- ISO/IEC 17025 Internal Auditor / Lead Auditor
- ISO 15189 Internal Auditor / Lead Auditor
- IRCA / CQI Lead Auditor certification is an advantage.
Education
Any Degree.
Preferred backgrounds include Biomedical, Biotechnology, Mechanical, Electrical, Electronics, Chemical or Industrial Engineering; Microbiology, Chemistry, Biotechnology, Physics, Life Sciences; BMLT/MMLT; Pharmacy; Biomedical Sciences or Quality Management.
Fresh graduates with relevant knowledge may apply.
Experience
Freshers and experienced candidates are welcome.
Freshers with knowledge of quality systems, laboratories, healthcare or ISO documentation may apply.
Experienced candidates with ISO auditing, laboratory quality systems, NABL accreditation, medical device quality, healthcare quality, consultancy or regulatory compliance experience are preferred.
Salary & Benefits
₹20,000 – ₹50,000 per month, depending on qualifications, experience, auditor certifications and technical competency.
Empanel Auditor & Tutor engagements are remunerated per audit day / training day.
Travel, accommodation and audit-day allowances are provided as per company policy.
Career Growth
Opportunity to work across medical device, testing, calibration and medical laboratory sectors, with structured mentoring and competency development towards Auditor, Lead Auditor and Tutor roles.
How to Apply
Send your updated CV along with your ISO qualifications, auditor certificates and audit experience/audit days completed.
Email: [email protected]
Contact: Joseph Christain J
PH:+91 95003 40122
Pay: ₹20,000.00 - ₹50,000.00 per month
Work Location: In person
