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Happy Reliable Surgeries logo

QA Specialist

5 - 10 years

8 - 12 Lacs

bengaluru

Posted:2 hours ago| Platform: Naukri logo

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Skills Required

cqa iso 13485 iso quality systems qms product life cycle management life sciences risk management six sigma hazard analysis

Work Mode

Work from Office

Job Type

Full Time

Job Description

  • Bachelors degree in Life Sciences, Engineering, or a related field.
  • 3-5 years of experience in QA roles with strong focus ondocumentation and compliance in the medical device industry.
  • In-depth knowledge of ISO 13485, FDA QSR, EU MDR, and risk management (ISO 14971).
  • 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 14971) 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).

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