QA/RA Manager at Hunarstreet Technologies Pvt Ltd · Delhi, Gurugram, Noida, Ghaziabad, Faridabad · 5 - 8 years · ₹5L - ₹10L / yr · Profitable · Posted 29 Jul 2026
Responsibilities
• Manage the QA/RA team
• Author and refine procedures, instructions, templates, and our quality manual to maintain quality management standards
• Maintain and monitor our quality system within the company: changes, CAPA, Non conformities, Complaints, PMS, continuous improvement, trend analysis, etc.
• Train all employees to the QMS, and assess skills, knowledge and QMS application.
• Perform internal audits to assess the company compliance with our QMS.
• Contribute to maintaining quality system related documentation including supplier records, audits, purchase and manufacturing batch information.
• Work with our Notified Body to maintain current certifications and achieve award of a CE mark and FDA approval on new products.
• Build knowledge and maintain surveillance of the many relevant quality standards
• Provide technical support and resolve quality issues with suppliers, customers or auditors including introduction of new or re-designed components and processes.
• Present technical data to internal / external audit and inspection groups as required.
Requirements
• Minimum of 5 years of Medical device QA/RA experience
• In depth familiarity with the FDA, ISO, MDD, EU MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management.
• Quality Management experience in a manufacturing/production environment.
• Conscientious and responsible
• A keen eye for detail and a results driven approach
• Strong communication and presentation skills.
• Excellent organizational and leadership skills
• Proficient in MS Office
• In depth understanding of quality control procedures and relevant legal standards
• Excellent math abilities and working knowledge of data analysis/statistical methods
Shubham Vishwakarma
Full Stack Developer - Averlon
About Hunarstreet Technologies Pvt Ltd
About
At Hunarstreet Technologies Pvt Ltd, we specialize in delivering India’s fastest hiring solutions, tailored to meet the unique needs of businesses across various industries. Our mission is to connect companies with exceptional talent, enabling them to achieve their growth and operational goals swiftly and efficiently.
We are able to achieve a success rate of 87% in relevancy of candidates to the job position and 62% success rate in closing positions shared with us.
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20RA Lead (7–8 years) | EU MDR + India (CDSCO) | Medical Devices
Role summary
Lead regulatory strategy and submissions for a medical device portfolio (hardware + software + accessories) across the EU MDR and India (CDSCO), with strong ownership of technical documentation and lifecycle change management.
Key responsibilities
- Own regulatory strategy and submission planning for EU MDR + India; build timelines, evidence plans, and dossier readiness trackers.
- Lead/author EU MDR Technical Documentation (Annex II & III): device description, GSPR checklist, risk/benefit, V&V summaries, clinical evaluation linkage, labeling/IFU, PMS/PMCF plans.
- Drive classification and portfolio mapping; support UDI basics and EMDN/basic UDI alignment (as applicable).
- Manage Notified Body interactions: questions, responses, meeting preparation, evidence packaging, and change justifications.
- Own India lifecycle activities: CDSCO changes (PAC), license maintenance, and regulatory communications.
- Ensure regulatory alignment for standards-driven evidence: ISO 14971, IEC 62304, IEC 60601, IEC 81001-5-1, usability (IEC 62366-1), biocompatibility (ISO 10993), and sterilization/reprocessing (as applicable).
- Support labeling/claims governance: intended use, indications, contraindications, and marketing claims review.
- Build and mentor the RA team; ensure version control, traceability, and audit-ready submissions.
Must-have qualifications
- 7–8 years in regulatory affairs for medical devices (Class II/III exposure preferred).
- Strong experience with EU MDR technical documentation and handling Notified Body queries/submission packages.
- Working experience with the CDSCO regulatory lifecycle (licenses/changes) is strongly preferred.
- Solid understanding of standards-driven evidence for HW+SW devices (14971, 62304, 60601, usability, biocomp).
Nice to have
- Exposure to US FDA 510(k), clinical evaluation/PMCF, cybersecurity documentation, and SaMD claims strategy.
- Experience with complex HW+SW systems and regulated accessories/instruments.
QA Project Manager
Location: Kochi, Kerala
Experience: 10–18 Years
Work Mode: Work from Office
Kerala based candidates preferrred
Role Overview
We are looking for an experienced QA Project Manager with 10–18 years of experience in software testing and quality assurance, including strong experience in project management within the QA domain.
The ideal candidate should have a strong QA/testing foundation combined with the ability to independently manage QA projects, delivery, resources, timelines, risks, stakeholders and releases.
This is not a pure QA/Test Lead position. The role requires proven experience in managing QA projects and driving end-to-end QA delivery.
Key Responsibilities
- Own and manage end-to-end QA projects from planning through release and closure.
- Define and execute QA project plans, schedules, milestones and delivery timelines.
- Manage QA resources, allocation, utilization and project priorities.
- Prepare project estimates, effort plans and resource requirements.
- Lead QA teams across multiple projects/workstreams.
- Monitor project progress, deliverables, dependencies, risks and issues.
- Drive SIT, UAT, regression, integration, system and release testing activities.
- Coordinate with Development, Business Analysis, Product, Business and other cross-functional teams.
- Manage client and stakeholder communication and provide regular project status updates.
- Own RAID management, risk mitigation and issue resolution.
- Track testing metrics, quality KPIs and project performance.
- Manage defect lifecycle and ensure timely resolution of critical issues.
- Coordinate with vendors and third-party teams where required.
- Ensure QA deliverables are completed within agreed timelines and quality standards.
- Support release planning, production readiness, go-live and post-release activities.
- Identify process improvements and drive QA best practices across projects.
- Provide leadership, mentoring and direction to QA team members.
Required Skills & Experience
- 10–18 years of overall IT experience, with significant experience in QA/Software Testing.
- Proven experience in QA Project Management / Project Management within the QA domain.
- Strong understanding of STLC, SDLC, Agile/Scrum and Waterfall methodologies.
- Experience managing QA teams and multiple workstreams.
- Strong experience in project planning, estimation, scheduling and resource management.
- Experience in stakeholder/client management.
- Strong experience in risk, issue, dependency and escalation management.
- Experience managing SIT, UAT, regression, integration and release activities.
- Strong reporting and project governance experience.
- Experience with tools such as JIRA, Azure DevOps, HP ALM, TestRail or similar.
- Strong communication, leadership and decision-making skills.
Preferred
- Experience managing enterprise QA projects.
- Experience working with distributed/onshore-offshore teams.
- Experience across banking, insurance, payments, retail, logistics or other enterprise domains.
- QA/Test management certifications such as ISTQB, CSM, PMP or equivalent are an advantage.
Follow CutshortShubham Vishwakarma
Full Stack Developer - Averlon