VACANCY ANNOUNCEMENT
Job Description – Asst. or Dy Quality Manager
Company: SD Biosensor India Pvt. Ltd.
Location: IMT Manesar, Gurugram
Department: Quality Assurance / Quality Control
Designation: Manager – Quality
Reporting To: Head – Quality / Factory Head
1. Job Purpose
To lead and manage the Quality Assurance (QA), Quality Control (QC), Incoming Quality Control (IQC), Risk Management, Design & Development Quality, and Post Market Surveillance (PMS) activities in compliance with ISO 13485, CDSCO Medical Device Rules, and applicable regulatory standards for IVD manufacturing operations.
The role is responsible for ensuring product quality, process compliance, regulatory readiness, supplier quality, product safety, and continuous improvement throughout the product lifecycle.
2. Key ResponsibilitiesA. Quality Management System (QMS)
- Implement, maintain, and continuously improve the Quality Management System in compliance with ISO 13485.
- Ensure compliance with company SOPs, quality procedures, GMP, and regulatory requirements.
- Manage document control systems including SOPs, records, specifications, forms, and revisions.
- Ensure effective implementation of:
- CAPA
- Change Control
- Deviation Management
- Risk Management
- Non-Conformance Management
- Maintain audit-ready documentation at all times.
B. Quality Assurance (QA)
- Ensure manufacturing and quality processes comply with approved procedures and specifications.
- Review and approve Batch Manufacturing Records (BMR) and quality documents.
- Monitor process compliance and shop-floor quality practices.
- Ensure line clearance, process validation, and product release activities are performed effectively.
- Handle deviations, investigations, and corrective actions.
- Conduct internal audits and support external/customer audits.
- Ensure implementation of data integrity and documentation compliance practices.
C. Quality Control (QC)
- Manage testing and inspection activities for raw materials, in-process samples, and finished goods.
- Ensure all QC testing is performed as per approved methods and specifications.
- Monitor laboratory practices, calibration, and testing equipment compliance.
- Review QC reports and ensure timely release of products.
- Investigate Out of Specification (OOS) and Out of Trend (OOT) results.
- Ensure laboratory documentation compliance and traceability.
D. Incoming Quality Control (IQC)
- Oversee incoming inspection activities for raw materials, consumables, reagents, packaging materials, and components.
- Ensure supplier materials meet defined quality standards before release to production.
- Coordinate supplier quality issues and material rejection handling.
- Maintain incoming inspection records and material traceability.
- Support supplier qualification and vendor audit activities.
- Monitor supplier quality performance and incoming rejection trends.
E. Risk Management
- Lead Risk Management activities as per ISO 14971 requirements for medical devices.
- Conduct risk assessments for:
- Products
- Processes
- Equipment
- Supplier-related risks
- Ensure risk analysis, mitigation, and control measures are properly documented.
- Participate in FMEA (Failure Mode and Effects Analysis) activities.
- Monitor effectiveness of risk control measures throughout product lifecycle.
- Support risk-based decision-making during deviations, CAPA, and change controls.
F. Design & Development Quality
- Support Design & Development activities in compliance with medical device regulations and ISO 13485.
- Participate in:
- Design reviews
- Design verification
- Design validation
- Design transfer activities
- Ensure Design History File (DHF) documentation compliance.
- Review product specifications, protocols, and validation reports.
- Coordinate risk management activities during product development stages.
- Ensure proper documentation and traceability for new product development projects.
G. Post Market Surveillance (PMS)
- Manage Post Market Surveillance activities for marketed products.
- Monitor customer complaints, product feedback, and field performance data.
- Conduct complaint investigations and trend analysis.
- Support vigilance reporting and regulatory reporting requirements.
- Coordinate Field Corrective and Preventive Actions (FSCA/Recall) if required.
- Prepare PMS reports and quality trend analysis for management review.
- Drive continuous product improvement based on market feedback and complaint analysis.
H. Regulatory & Compliance Management
- Ensure compliance with:
- ISO 13485
- CDSCO Medical Device Rules
- Internal SOPs and quality standards
- Customer and regulatory audit requirements
- Coordinate internal, external, regulatory, and customer audits.
- Ensure timely closure of audit observations and CAPA implementation.
- Maintain regulatory and quality compliance documentation.
I. Supplier Quality & Vendor Management
- Participate in supplier qualification and vendor audits.
- Monitor supplier quality performance (QCD – Quality, Cost, Delivery).
- Coordinate supplier corrective actions for quality issues.
- Maintain Approved Vendor List (AVL) compliance documentation.
J. Cross-Functional Coordination
Coordinate closely with:
- Production
- R&D
- Regulatory Affairs
- Supply Chain & Stores
- Engineering & Maintenance
- Procurement
to ensure product quality, compliance, and operational efficiency.
K. Team Management
- Lead and mentor QA, QC, and IQC teams.
- Allocate responsibilities and monitor departmental KPIs.
- Conduct quality trainings and awareness programs.
- Ensure adherence to SOPs, compliance standards, and safety requirements.
- Drive accountability and continuous improvement culture.
3. Key Deliverables / KPIs
- Successful ISO 13485 and regulatory audit outcomes
- Reduction in non-conformances and deviations
- CAPA closure effectiveness
- Incoming rejection reduction
- Product complaint reduction
- On-time batch release performance
- Supplier quality improvement
- PMS effectiveness and complaint closure timelines
- Risk mitigation effectiveness
4. Educational Qualification
- Bachelor’s Degree in Biotechnology / Microbiology / Pharmacy / Life Sciences / Engineering
- Master’s Degree or Quality Certifications preferred
5. Experience
- 8–12 years of experience in QA/QC within Medical Devices / Pharma / IVD industry
- Strong exposure to ISO 13485 and regulatory audits
- Experience in Risk Management and Post Market Surveillance preferred
6. Skills Required
- Strong knowledge of:
- ISO 13485
- ISO 14971 Risk Management
- Medical Device Regulations
- CAPA and audit systems
- QC laboratory practices
- Validation and documentation systems
- ERP knowledge (SAP preferred)
- Strong analytical and problem-solving skills
- Leadership and team management capability
- Excellent communication and coordination skills
7. Behavioral Competencies
- High integrity and compliance-focused mindset
- Strong attention to detail
- Critical thinking and investigation capability
- Decision-making under pressure
- Continuous improvement approach
8. Special Requirements (IVD Industry Specific)
Understanding of:
- IVD manufacturing processes
- Reagents, chemicals, and consumables handling
- Cleanroom compliance
- Product traceability systems
- Design Control requirements
- PMS and complaint handling systems
- Handling ISO / CDSCO / customer audits
9. Authority Matrix
- Approval authority for quality documents and product release
- CAPA approval and investigation authority
- Authority to stop production during critical quality non-compliance
- Audit coordination authority
- Supplier quality approval participation
10. Reporting & Documentation
- Quality KPI reports
- CAPA and deviation reports
- PMS and complaint trend reports
- Audit reports and compliance documentation
- IQC/QC reports
- Validation and risk management records
11. Working Conditions
- Factory-based role with regular shop-floor monitoring
- High involvement during audits and inspections
- Frequent cross-functional coordination
- Occasional vendor/customer audit participation
How to Apply
Interested candidates can reach out directly via:
Email: [email protected] & [email protected]
WhatsApp/Call: +91-9560727259
Job Type: Full-time
Pay: ₹604,055.36 - ₹1,325,355.94 per year
Benefits:
- Cell phone reimbursement
- Commuter assistance
- Food provided
- Health insurance
- Leave encashment
- Paid sick time
- Provident Fund
Work Location: In person
