Quality Assurance Executive _QMS

Optrascan; Pune District; On-site; INR 5,00,000 - 8,00,000; Full time

Job summary

A diagnostics technology company in Pune is seeking a Quality Assurance professional to support the Quality Management System across its Digital Pathology Systems. The successful candidate will ensure compliance with various ISO standards and collaborate with cross-functional teams. Candidates should have a Diploma or Bachelor's in Mechanical or Engineering, and 3-5 years of relevant experience. Strong attention to detail and organizational skills are essential.

Qualifications

• 3-5 years of experience in a quality or manufacturing environment.
• Familiarity with ISO 13485 and medical device regulations.
• Certification as Internal Auditor ISO 13485.

Responsibilities

• Assist in maintaining and updating QMS documentation.
• Help coordinate internal audits and prepare documentation for external audits.
• Support the training process by organizing sessions.

Skills

Attention to detail

Communication skills

Organizational skills

Microsoft Office

Education

Diploma or Bachelor's in Mechanical Engineering or related field

Job description

About the Role

OptraSCAN is advancing precision diagnostics through digital pathology. As Quality Assurance, you will support the integrity and effectiveness of the Quality Management System (QMS) across our Digital Pathology Systems and Software as a Medical Device (SaMD) portfolio. You will contribute to compliance with ISO 13485:2016, 21 CFR 820, EU IVDR, MDSAP, and Indian Medical Device Rules 2017, working across design, manufacturing, and post-market activities. This role collaborates with R&D, Regulatory Affairs, Manufacturing, Supply Chain, and Commercial teams.

Core skills

• Assist in maintaining and updating QMS documentation (SOPs, Work Instructions, Records).
• Help coordinate internal audits and prepare documentation for external audits.
• Support the training process by organizing sessions and maintaining training records.
• Perform basic QC checks and inspections under supervision.
• Assist with tracking and follow-up on CAPA actions.
• Help maintain supplier documentation and support risk management files.
• Ensure proper document control and record retention in compliance with ISO 13485.
• Promote awareness of quality procedures across departments.

Qualifications

• Diploma or Bachelor s in Mechanical, Engineering, or related field.
• 3-5 years of experience in a quality or manufacturing environment.
• Familiarity with ISO 13485 and medical device regulations is an advantage.
• Certification - Internal Auditor ISO 13485
• Training certificates - ISO 14971

Skills Required

• Basic understanding of QMS principles and ISO standards.
• Good attention to detail and documentation accuracy.
• Strong organizational and communication skills.
• Proficient in Microsoft Office (Word, Excel, Outlook).
• Ability to follow procedures and work collaboratively in a team.