Position: Quality Head
Department: Quality Assurance & Quality Control
Location: Imphal, Manipur
Industry: Medical Device Manufacturing
Reporting To: Managing Director / Plant Head
Company Overview
We are a leading Medical Device Manufacturing Company engaged in the manufacturing of Catheters, PICC Kits, PD Kits, Central Venous Catheters, and other sterile surgical medical devices. We are looking for an experienced and dynamic Quality Head to strengthen our Quality Management System and drive continuous improvement across manufacturing operations.
Job Purpose
The Quality Head will be responsible for leading Quality Assurance and Quality Control functions, ensuring compliance with ISO 13485, Medical Device Regulations, and applicable quality standards. The role will focus on reducing product defects, improving process quality, managing audits, implementing CAPA, and driving operational excellence throughout the organization.
Key ResponsibilitiesQuality Management System (QMS)
- Develop, implement, and maintain Quality Management Systems in accordance with ISO 13485 and Medical Device Regulations.
- Ensure compliance with company quality policies, SOPs, procedures, and work instructions.
- Monitor and improve overall quality performance across the organization.
Quality Assurance & Quality Control
- Lead QA and QC teams to ensure product quality and process compliance.
- Monitor incoming, in-process, and final inspection activities.
- Review and approve quality records, batch records, and quality reports.
- Analyze rejection, rework, and defect trends and implement corrective actions.
CAPA & Continuous Improvement
- Lead Root Cause Analysis (RCA) investigations using quality tools.
- Ensure effective implementation and closure of CAPA.
- Drive quality improvement projects to reduce rejection and improve process efficiency.
- Promote a culture of continuous improvement throughout the plant.
Regulatory Compliance
- Ensure compliance with:
- ISO 13485
- CDSCO / MDR Requirements
- GMP Requirements
- Applicable Regulatory Standards
- Maintain audit readiness at all times.
Audit Management
- Plan and conduct Internal Audits.
- Coordinate Customer Audits, Certification Audits, and Regulatory Inspections.
- Ensure timely closure of audit observations and non-conformities.
Validation & Documentation
- Review and approve validation protocols and reports.
- Ensure proper documentation control and record management.
- Support process, equipment, and sterilization validation activities.
Customer Complaint Management
- Investigate customer complaints and quality issues.
- Ensure timely implementation of corrective and preventive actions.
- Monitor complaint trends and recommend preventive measures.
Team Leadership
- Lead, mentor, and develop QA/QC personnel.
- Conduct quality awareness and compliance training programs.
- Establish departmental goals and performance metrics.
Qualification
- B.Tech / B.E. / M.Tech (Biomedical, Mechanical, Production, Industrial Engineering) OR
- M.Sc. / B.Pharm / M.Pharm or equivalent qualification.
Experience
- 8–15 years of experience in Quality Assurance/Quality Management.
- Minimum 5 years of leadership experience in Medical Device Manufacturing.
- Experience in Catheters, Disposable Medical Devices, Surgical Products, Sterile Devices, or Interventional Products preferred.
Required Skills
- ISO 13485
- CAPA Management
- Internal & External Audits
- Root Cause Analysis (RCA)
- Risk Management
- Validation Management
- Quality Control Systems
- Regulatory Compliance
- Documentation Control
- Team Management
- Problem Solving & Decision Making
Key Performance Indicators (KPIs)
- Reduction in Product Rejection %
- Reduction in Customer Complaints
- CAPA Closure Effectiveness
- Audit Compliance Score
- First Pass Yield Improvement
- Reduction in Rework and Scrap
- Regulatory Compliance Status
- Process Improvement Implementation
Preferred Candidate
Candidates from Medical Device Manufacturing Companies involved in Catheters, PICC Lines, PD Kits, Surgical Disposables, Dialysis Products, IV Devices, or Sterile Medical Devices will be given preference.
Salary
Best in Industry (Based on Experience & Competency)
Pay: ₹35,000.00 - ₹80,000.00 per month
Work Location: In person
