Quality Assurance Executive _QMS

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.