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Quality Assurance (QA) Specialist

HRS NavigationBengaluru, Karnataka, India

3 days ago

Job description

Company Description

HRS Navigation is a Bangalore-based healthcare company specializing in innovative computer-assisted surgery solutions, one of the few companies globally focused on this field. We are proudly the first Indian company to achieve this, we operate in highly specialized areas such as Neurosurgery, ENT, and Spine surgery. Our flagship product, easyNav™, significantly improves surgical workflows through advanced image guidance and navigation techniques.

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, high-impact environment.

Role : QA Professional

Experience : 3 To 5

Location : Bangalore

What We’re Looking For :

Bachelor’s degree in Life Sciences, Engineering , or a related discipline
3–5 years of experience in Quality Assurance , with strong focus on compliance and documentation in the medical device industry
Strong knowledge of ISO 13485, FDA QSR (21 CFR Part 820), EU MDR , and ISO 14971 risk management principles
Hands-on experience with QMS documentation , CAPA , and audit readiness
Familiarity with FMEA, hazard analysis , and other risk management tools
High attention to detail and a strong drive for accuracy and quality
Experience in startups or fast-moving environments is a plus
Excellent verbal and written communication skills

Preferred Qualifications :

CQA , Six Sigma, or similar quality certifications

Experience with SaMD (Software as a Medical Device)

Working knowledge of eQMS tools such as MasterControl, Greenlight Guru, Qualio, SimplerQMS, ETQ, or Qualityze

Key Responsibilities :

Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485, FDA QSR, EU MDR

Lead and manage CAPAs, non-conformances, and change controls

Support risk management activities (ISO 14971) and product lifecycle quality efforts

Collaborate cross-functionally with Engineering, Regulatory, and Manufacturing teams

Support and prepare for internal and external audits and regulatory inspections

Serve as Subject Matter Expert (SME) during audits when needed

Maintain and update quality documentation : SOPs, work instructions, protocols

Manage Design History File (DHF) and Device Master Record (DMR)

Assist in selection and implementation of electronic QMS tools

Track and report on quality metrics and trends for continuous improvement

Participate in supplier evaluations and audits to ensure compliance

Review and approve quality documents including SOPs, protocols, and reports

Oversee document control and training systems to ensure compliance

Ensure effectiveness and documentation of quality training programs

Support post-market surveillance and complaint handling as required

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Quality Assurance Specialist • Bengaluru, Karnataka, India