Quality Assurance Officer

Job Category: QA

Reporting to: Head – QA/CTO

Location: Thane, Maharashtra

Job Type: Full-time

Education: B.E/ B. Tech in Biomedical Engineering/Biotechnology, MSc – Chemistry, or B. Pharm

Roles:

To work in Quality Assurance activities related to creating, validating, and implementing Standard Operating Procedures (SOPs), documentation, and quality management system requirements. Ensure compliance with MDR, ISO 13485, ISO 3826, USFDA QSR – CFR Part 820, and other international standards. Handle regulatory and customer audits while supporting customer requirements related to quality and other statutory needs.

Responsibilities:

• Develop, validate, and implement SOPs across all manufacturing and operational phases.

• Ensure all processes meet quality plans and regulatory requirements, including in-process checks.

• Oversee process validations and ensure compliance with MDR and applicable international standards.

• Prepare and maintain technical documents, including validation reports, deviation records, and batch release documentation.

• Conduct regular audits and ensure readiness for customer and regulatory inspections.

• Address non-conformances through CAPA (Corrective and Preventive Actions) and ensure timely closure.

• Track QMS elements such as change control, deviation management, and supplier performance monitoring.

• Support supplier audits and take informed decisions regarding vendor/service provider approvals.

• Collaborate with the team to maintain compliance with ISO 13485, ISO 3826, and similar standards.

• Conduct employee training sessions on SOPs and quality protocols.

Qualifications and Skills Necessary:

• Master’s degree or equivalent (or higher) in Chemistry, Polymer Science, Microbiology, or Biotechnology.

• Proven knowledge of QA methods and techniques in medical devices or biotech manufacturing.

• Experience in ISO 13485, EU MDR, USFDA QSR – CFR Part 820, and similar quality standards.

• Strong understanding of QMS elements, including CAPA, change control, and deviation management.

• Hands-on experience with regulatory audits and inspection requirements.

• Ability to work both independently and in a team, with strong attention to detail and organizational skills.