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QA Associate I

QA Associate I

Cytiva

2 - 5 years

3 - 6 Lacs

bengaluru

Posted:3 days ago| Platform:

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Skills Required

medical devices manager quality assurance iso analytical healthcare product design risk management continuous improvement monitoring auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

In this role, you will have the opportunity to:

Design Control & Product Development:

Ensure QMS & Regulatory Compliance

Support adherence to FDA regulations and ISO standards by maintaining quality processes and documentation throughout product development

Quality Representation in Projects

Actively participate in design and development teams, review and approve documentation, and ensure requirement management aligns with quality standards.

Risk Management & Cross-Functional Collaboration

Collaborate with R&D, Operations, and RA to assess product risks using appropriate tools and contribute to risk evaluations during development and post-launch.

Audit Readiness & Continuous Improvement

Help keep projects audit-ready, assist during internal/external audits, and support quality initiatives and training activities within BDC.

Regulatory Knowledge & System Updates

Stay current with medical device/IVD standards and regulations and ensure timely updates to relevant QA system components.

The essential requirements of the job include:

The ideal candidate should hold a M.Tech /B.Tech/BE degree in engineering, with strength in product design processes of multi-disciplinary products. However, if the candidate has a good technical understanding and is able to learn the technical aspects in the products fast and to communicate in a technical organization, other education at university level relevant for QA work could be accepted.

Experience: 2-5 years in Quality Assurance within Healthcare/Medical Devices, with proven expertise in design control processes and regulated environments (FDA 21 CFR 820, ISO 13485, MDR, IVDR).
Technical Expertise: Hands-on experience in risk management (ISO 14971), usability, requirement management, systems engineering, cybersecurity, validation/verification, and IEC 62304 compliance.
Domain Knowledge: Strong understanding of immunoassay principles and product lifecycle for immunoassay devices (hardware and software), including analytical performance verification.
Process & Standards: Familiarity with global regulatory standards across major markets, system integration testing, and lean process development.

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QA Associate I