Website:
eltcorporate.com
Job details:
Company: Assuretica
Engagement Type: Freelance / Contractual / Empanelment
Location: Pan India
Work Mode: On-site / Remote, depending on audit requirements
Job Description
Assuretica is inviting applications from experienced ISO 9001 and ISO 13485 Auditors, Lead Auditors and Technical Experts for empanelment as part of its Contract Auditor Network.
We are looking for professionals with strong auditing experience, relevant industry exposure and demonstrated technical competence who can undertake independent certification audits on behalf of Assuretica.
Key Responsibilities
- Conduct ISO 9001 and/or ISO 13485 audits as per assigned scope.
- Lead or participate in audit teams depending on approved competence.
- Review Quality Management Systems, processes, records and regulatory compliance.
- Prepare clear, accurate and timely audit reports.
- Identify non-conformities and objectively evaluate corrective actions.
- Maintain confidentiality, independence and impartiality during all audit assignments.
- Participate in competence evaluations, witnessed audits and periodic performance reviews.
- For ISO 13485 assignments, audit within approved medical-device technical areas based on demonstrated competence.
- Coordinate professionally with the audit team and Assuretica certification personnel.
The programme specifically requires auditors to be evaluated according to their standard, technical area, audit role and documented competence rather than merely holding an auditor certificate.
Eligibility & Preferred Qualifications
- Auditor / Lead Auditor qualification in ISO 9001 and/or ISO 13485.
- Relevant graduation / professional / technical qualification.
- Demonstrable industry experience in quality, manufacturing, engineering, medical devices or related sectors.
- Previous experience conducting third-party or certification audits preferred.
- Experience working with an accredited Certification Body will be an advantage.
- For ISO 13485 auditors, relevant experience in one or more medical-device technical areas is preferred.
- Knowledge of medical-device regulatory frameworks such as India MDR 2017, EU MDR and/or FDA requirements will be an advantage.
- Strong report-writing, communication and analytical skills.
- Willingness to travel for audit assignments where required.
Assuretica's competence register is intended to assess education, auditor training, industry experience, audit experience, technical approvals, regulatory knowledge, geographical availability and impartiality.
ISO 13485 Technical Experience Preferred
Candidates having experience in areas such as:
- Non-active medical devices
- Active medical devices
- Sterile medical devices
- IVD medical devices
- Medical-device software
- Medical-device manufacturing and QMS
- Sterilization processes
- Regulatory compliance
ISO 13485 auditors will be mapped according to the medical-device technical areas in which sufficient competence can be demonstrated.
Engagement Requirements
Selected professionals may be required to provide:
- Updated CV
- Educational qualification certificates
- Auditor / Lead Auditor certificates
- Audit logs and audit-day experience
- Evidence of relevant industry experience
- Technical-area experience details
- Current Certification Body associations
- Availability and geographical coverage
- Expected audit-day professional fee
- Conflict-of-interest / impartiality declaration
The planned approval process includes document verification, competence evaluation, technical-area mapping, interview, knowledge assessment, witnessed/observed audit, contractual documentation and ongoing monitoring.
Preferred Locations
Applications are invited from professionals across India, particularly from Delhi-NCR, Chandigarh, Ludhiana, Jaipur, Mumbai, Pune, Ahmedabad, Vadodara, Bengaluru, Hyderabad, Chennai, Kochi, Indore, Bhopal, Kolkata and Bhubaneswar.
Important
This is an empanelment / contractual auditing opportunity. Auditors engaged for certification audits are expected to remain independent from consultancy or implementation activities that may create a conflict of interest.
Interested candidates may share their updated CV, Lead Auditor certificates, audit experience/logs, technical expertise, current location, availability and expected audit-day fee.
Subject: Application for Contract Auditor – ISO 9001 / ISO 13485
Short Job Portal Title:
ISO 9001 / ISO 13485 Lead Auditor – Freelance / Contract | Pan India
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