QA Head ( Plastic Medical Device)

Job Summary:We are seeking an experienced Quality Assurance Manager with a strong background in Pharmaceutical Packaging industry as well ISO 13485:2016/ 15378 also regulatory compliance for medical devices. This role involves overseeing all quality assurance activities, ensuring product and process quality, and driving continuous improvement initiatives. The ideal candidate will have robust leadership skills, excellent knowledge of QMS, and a proactive approach to maintaining compliance and product integrity.Key Responsibilities:

• Define and implement the quality assurance strategy aligned with organizational goals.
• Develop, implement, and maintain SOPs, work instructions, and controlled documents.
• Lead and mentor the QC team across documentation, validation, and compliance function
• Ensure compliance with all regulatory requirements and facilitate successful audits (regulatory, customer, and internal).
• Conduct internal audits and manage CAPA (Corrective and Preventive Action) processes.
• Validate Molds, processes, and equipment (IQ/OQ/PQ) before production initiation.
• Approve supplier qualifications and verify COAs for raw materials.
• Review and approve artwork, packaging specifications, and change controls
• Prepare and maintain traceability systems, line clearance procedures, and batch records.
• Define in-process quality checkpoints and lead IPQC training and planning.
• Investigate deviations and non-conformances with detailed root cause analysis.
• Lead training programs, update skill matrices, and ensure regulatory compliance.
• Oversee the documentation process, ensuring proper entries and audit-readiness.
• Support continuous improvement initiatives to enhance product and process quality.
• Collaborate with production for product lifecycle quality planning.
• Represent the company during regulatory inspections and customer audits.

Build and sustain a strong quality culture throughout the organization

Job Type: Full-time

Pay: ₹35,000.00 - ₹45,000.00 per month

Benefits:

• Health insurance
• Provident Fund

Schedule:

• Day shift
• Rotational shift

Supplemental Pay:

• Yearly bonus

Work Location: In person