EMPOWERING ASSURANCE SYSTEMS PVT LTD

13485 - MDQMS-LABQMS-15189

Job Description · Chennai (WFH for Empanel Auditor & Tutor) - travel across India & overseas as required

Reference: JO-306 | Open from: 02 Sep 2026 | Applications close: 31 Jul 2027

Position Details

Position: 13485 - MDQMSLABQMS-15189

Company: EMPOWERING ASSURANCE SYSTEMS PVT LTD

Department: 13485 - MDQMSLABQMS-15189

Employment Type: Empanel

Location: Chennai (WFH for Empanel Auditor & Tutor) - travel across India & overseas as required

Vacancies: 5

Experience: 5 to 8 years

Qualification: Any degree

Languages: English, Tamil

Recruiter: Loshna.R

Annual CTC: INR 4 - 6 LPA

Role & Responsibilities

13485 GROUP - MDQMS / LABQMS / 15189

Junior Auditor / Auditor / Empanel Auditor & Tutor - Medical Devices, Testing & Medical Laboratories

Empowering Assurance Systems Pvt Ltd | Chennai, with travel across India and overseas as required | Work From Home available for Empanel Auditor and Tutor engagements | Reports to: Technical Manager - Certification

SCHEME GROUP COVERED

- ISO 13485:2016 - Medical Device Quality Management Systems (MDQMS)
- ISO/IEC 17025:2017 - Competence of Testing and Calibration Laboratories (LABQMS)
- ISO 15189:2022 - Medical Laboratories, Requirements for Quality and Competence

ABOUT THE ROLE

Empowering Assurance Systems(EAS)/(IAS) is a certification, inspection, testing, training and consultancy organisation. We are seeking career-oriented professionals to support audit, documentation, implementation, consultancy and certification activities across medical device manufacturing, testing and calibration laboratories, and medical and diagnostic laboratories. Candidates with experience in quality systems, laboratories, healthcare, medical devices or auditing are encouraged to apply.

KEY RESPONSIBILITIES

1. Audit execution

- Conduct gap audits, documentation, implementation reviews, internal audits, ISO 13485, ISO/IEC 17025 and ISO 15189.
- Conduct iso trainings against ISO 13485, ISO/IEC 17025 and ISO 15189.
- Assist Lead Auditors during Stage 1, Stage 2, surveillance and recertification audits.
- Prepare audit plans, scheme-specific checklists, sampling plans and audit itineraries.
- Conduct compliance reviews and gap assessments, interview process owners and gather objective evidence against every applicable clause.
- Assess design and development controls, risk management files, traceability, validation and verification records and supplier controls for medical devices.
- Assess measurement traceability, method validation and verification, uncertainty of measurement, equipment calibration and maintenance and internal quality control for laboratories.
- Assess sample handling and traceability, quality assurance programmes, competency management and patient-focused laboratory services for medical laboratories.
- Raise nonconformity reports classified as major,



minor or opportunity for improvement, with clear requirement, evidence and nonconformity statements.
- Review root cause analysis and CAPA plans, verify implementation and effectiveness, and close out findings within defined timelines.
- Prepare complete audit reports, audit day records and recommendation notes supporting the certification decision and technical review.

REQUIRED SKILLS - MUST HAVE

- Working knowledge of quality management system principles and clause structure.
- Audit planning, sampling, evidence gathering, interviewing and reporting.
- Nonconformity classification, root cause analysis and CAPA management.
- Risk-based thinking and risk management principles.
- Validation and verification concepts.
- Documentation development and record keeping.
- Technical report writing in clear, exact English.
- Communication, presentation and client-coordination skills.
- Microsoft Office - Word, Excel and PowerPoint.
- Willingness to travel across India and overseas.

PREFERRED SKILLS - GOOD TO HAVE

- Medical device quality systems: design controls, regulatory requirements, traceability, supplier management and post-market surveillance.
- Laboratory quality systems: measurement traceability, uncertainty of measurement, proficiency testing and internal quality control.
- Medical laboratory operations: pre-analytical, analytical and post-analytical phases, competency assessment and laboratory risk management.
- NABL accreditation project experience.
- Healthcare quality management systems and regulatory compliance.
- Integrated Management System exposure across ISO 9001, ISO 14001 and ISO 45001.
- Experience with certification bodies, inspection bodies, laboratories, consultancies or training organisations.
- Delivering training and awareness programmes as a Tutor.

PREFERRED PROFESSIONAL QUALIFICATIONS

- Internal Auditor: ISO 13485, ISO/IEC 17025, ISO 15189 or IMS Internal Auditor.
- Lead Auditor: ISO 13485, ISO/IEC 17025 or ISO 15189 Lead Auditor. IRCA / CQI Lead Auditor qualifications are an added advantage where applicable.

EDUCATIONAL QUALIFICATION

Any degree. Preferred backgrounds include B.E or B.Tech in Biomedical, Biotechnology, Mechanical, Electrical, Electronics, Chemical or Industrial Engineering; B.Sc or M.Sc in Microbiology, Chemistry, Biotechnology, Physics or Life Sciences; Medical Laboratory Technology, BMLT or MMLT; Pharmacy; Biomedical Sciences; or Quality Management.

EXPERIENCE

Required experience:



5 to 8 years of relevant experience.

Experienced: internal audit experience; laboratory quality system implementation; ISO consultancy experience; documentation development and control; quality assurance and quality control activities; medical device quality management; NABL accreditation projects; healthcare quality management systems; regulatory compliance activities.

COMPENSATION

Indicative annual CTC: INR 4 - 6 LPA (Lakhs Per Annum). Actual CTC is based on experience and is fixed individually against educational qualification, auditor qualifications held, number of schemes handled, audit days completed, consultancy experience, industry experience and technical competency. Internal auditors, lead auditors, consultants, tutors and experienced certification professionals are all welcome to apply and will be assessed on the same basis. Empanel Auditor and Tutor engagements are remunerated per audit day or per training day.

WORK MODE AND TRAVEL

Chennai-based role with travel across India and overseas as required. Work From Home is available for Empanel Auditor and Tutor engagements. Travel, accommodation and audit-day allowances are provided as per company policy.

WHY JOIN US

Exposure to medical device, testing, calibration and medical laboratory sectors, structured witness and mentoring support towards Lead Auditor qualification, sponsorship of scheme competence development, and a clear progression path from Junior Auditor to Auditor, Lead Auditor and Tutor.

SELECTION PROCESS

HR screening call, face-to-face interview, final round. Apply with your updated CV listing your qualifications, auditor certificates and audit days completed.

KEYWORDS

Junior Auditor, ISO 13485 Auditor, ISO 17025 Auditor, ISO 15189 Auditor, Medical Device Quality Executive, Laboratory Quality Executive, NABL Consultant, Quality Assurance Executive, Internal Auditor, Lead Auditor, Empanel Auditor, Tutor, ISO Consultant, Medical Laboratory Quality Coordinator, Calibration Laboratory Executive, Testing Laboratory Quality Executive, Healthcare Quality Executive, IMS Executive, Compliance Executive, Quality Systems Executive, Chennai.

Selection Process

#

Interview Round

Mode

1

HR Screening

PHONE

2

Face To Face

Face to Face

3

Final Round

Face to Face

How to Apply

Reply to the email this Job Description was sent with, or contact Loshna.R at [email protected].

This Job Description is issued for recruitment purposes and is valid until 31 Jul 2027. It describes the role as advertised and does not by itself constitute an offer of employment.

Pay: ₹400,000.00 - ₹600,000.00 per year

Application Question(s):

- How many internal and external audits have you conducted independently?
- What is your current CTC (annual)?
- What is your notice period?

Work Location: In person

📌 13485 - MDQMS-LAB (Chennai)
🏢 Empowering Assurance Systems
📍 Chennai