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10 Bscic Certifications Jobs
Lead Auditor / Technical Reviewer (ISO 13485)
6-8 years
Faridabad
1 vacancy
Lead Auditor / Technical Reviewer (ISO 13485)
Bscic Certifications
posted 2d ago
Job Role Insights
Fixed timing
Key skills for the job
Job Description
Job requirements:
- Prepare and manage technical files for CE marking of both medical and non-medical devices.
- Conduct Stage 1 audits as per ISO 13485 and CDSCO Schedule 4 & 5 requirements.
- Perform technical reviews, schedule assessments, and manage Stage 1 assessments remotely from the office.
- Oversee Schedule 5 and Stage 2 audits for MDQMS, which may require on-site visits and outstation travel a few times per month.
- Progress to become a lead auditor or tutor for ISO 13485 Internal Auditors and Lead Auditor courses based on performance.
- Assist in the coordination of audits and ensure compliance with regulatory standards.
- Collaborate with Sales, Assessment, and Compliance teams to ensure smooth execution of processes.
- Attend customer queries and resolve issues efficiently by coordinating with internal teams.
- Ensure timely submission and follow-up of reports.
- Review assessor payment invoices and ensure timely processing.
- Execute B014 and B021 MDQMS procedures effectively.
- Track and update MDQMS reports in internal software and maintain proper documentation in respective folders.
- Verify, validate, and check the suitability of certifications and reports.
- Act as a certificate checker for MDQMS cases.
- Amend BSCIC procedures and formats as per new regulatory requirements.
- Update and maintain regulatory Code Matrix, CR & CDR, and Triennial Matrix for MDQMS.
- Manage and update compliance documents, including B027, B066, B063 & B031 for MDQMS & Notified Body.
- Upload required files on the Sugam Portal for MDR compliance.
- Issue Auditor & Technical Expert (T.E.) empanel letters post MD approval.
- Confirm payments from the accounts department.
- Coordinate with Sales & Assessment teams for sourcing and onboarding new resources.
Competency Requirement:
- Male
- Education: B. Tech / B.Sc. / M.Sc. in Biotechnology or Medical Devices bachelor s degree in pharmacy, Biomedical Engineering, Life Sciences, or a related field with relevant experience in quality assurance
- Certifications: ISO 13485 Lead Auditor (LA) certification required
- Minimum 6-8 years of total experience Manufacturing & Quality Assurance (QA) of Medical Devices along with auditing experience.
- Prior third-party auditing experience with documented logs.
- Strong understanding of applicable regulatory frameworks and statutory compliances
- Proficient in medical device , manufacturing processes, and quality control methodologies
- Excellent communication and presentation skills
- Strong client relationship management abilities
- Good listening and analytical skills
- Proficiency in written and spoken English
- Must have own conveyance
Employment Type: Full Time, Permanent
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based on 48 employees
Strict timing
Monday to Saturday
No travel
Day Shift
Bscic Certifications Benefits
Job Training 
Soft Skill Training 
Cafeteria 
Health Insurance 
Work From Home 
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