QA Specialist

3 days ago

Bengaluru, Karnataka, India HRS Navigation Full time ₹ 9,00,000 - ₹ 12,00,000 per year

HRS Navigation is aggressively expanding its business and further developing our team of talented professionals. You can We are actively seeking out the best and brightest to join our team. If you want to make a difference and join a team that is changing the surgical workplace then we want to hear from you

QA Specialist

Role Summary:

We're looking for a dedicated QA professional with hands-on experience in medical device quality systems, compliance, and documentation. someone who thrives in a fast-paced, highimpact environment.

Role: QA Specialist

Experience: 3 To 5

Location: Bangalore

  • Bachelor's degree in Life Sciences, Engineering, or a related field.
  • 3–5 years of experience in QA roles with strong focus on documentation and compliance in the medical device industry.
  • In-depth knowledge of ISO 13485, FDA QSR, EU MDR, and risk management (ISO
  • Proven experience with QMS documentation management and inspection/audit readiness.
  • Familiarity with risk management tools (e.g., FMEA, Hazard Analysis).
  • Strong attention to detail and high standards for documentation accuracy.
  • Experience in a startup or fast-paced, resource constrained environment preferred.
  • Excellent written and verbal communication skills.

Preferred Qualifications:

  • Certified Quality Auditor (CQA), Six Sigma, or similar certifications.
  • Experience with software as a medical device (SaMD) is a plus.
  • Familiarity with electronic QMS systems (e.g., MasterControl, Greenlight Guru, Qualio, SimplerQMS, ETQ, and Qualityze EQMS).

Skill Required:

  • Contribute to building and maintaining our QMS in line with ISO 13485, FDA 21 CFR Part 820, EU MDR and so on.
  • Own and manage CAPAs, non-conformances, and change controls.
  • Support risk management activities (ISO and product lifecycle management.
  • Work cross-functionally with engineering, regulatory, and manufacturing teams to support design controls and risk management.
  • Support and prepare for audits and inspections (internal and external).
  • Assist in regulatory inspection readiness and participate as SME where needed.
  • Develop, revise, and maintain quality documentation (SOPs, work instructions, protocols).
  • Support the development and maintenance of Design History File (DHF) and Device Master Record (DMR).
  • Help implement electronic QMS tools suitable for a growing organization.
  • Monitor and analyze quality metrics and trends to identify improvement opportunities.
  • Participate in supplier evaluations, audits and ensure ongoing quality compliance.
  • Review and approve quality documents including SOPs, work instructions, protocols, and reports.
  • Maintain document control and training systems per QMS requirements.
  • Ensure quality-related training programs are current, effective, and fully documented.
  • Support complaint handling and post-market surveillance activities (as applicable).

Be a part of something meaningful — where Technology Meets Purpose and every day helps Save Lives.

Interested candidates, please send resume to: [email protected]

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