Quality Assurance Specialist

2 weeks ago

Hyderabad, India Alp Consulting Ltd. Full time

Job Responsibilities Quality Management System (QMS):

Implementing and maintaining a QMS (like ISO 13485) to ensure products meet quality, safety, and regulatory standards. Regulatory Compliance:

Identifying, interpreting, and ensuring adherence to relevant medical device regulations for market entry and ongoing compliance. Documentation Management:

Creating, reviewing, and controlling technical files, regulatory submissions (e.g., 510(k)), quality agreements, and internal procedures. Design Control & Development Support:

Providing QA/RA input and support for design and development activities to ensure compliance from the outset. Risk Management:

Participating in risk management activities throughout the product life cycle to identify and mitigate potential hazards. Post-Market Surveillance & Vigilance:

Monitoring device performance in the market, investigating customer complaints and non-conformity, and managing vigilance reporting. Supplier Management:

Supporting the management of supplier quality and compliance. Internal Audits & Process Improvement:

Conducting internal audits and leading initiatives to improve processes and ensure adherence to QMS requirements.

Key Skills & Qualifications

Regulatory Expertise: Deep knowledge of global medical device regulations and standards.

Problem-Solving & Attention to Detail: Crucial for interpreting regulations, documenting processes, and resolving issues.

Communication Skills: To coordinate with internal departments and external stakeholders.

Bachelor's Degree: In a relevant field such as engineering, life sciences, or a related technical discipline.

Experience: Previous experience in QA/RA within the medical device industry is an advantage.

  • Quality Assurance Specialist

    2 weeks ago

    Hyderabad, India OrbitCode Full time

    Title: Quality Assurance Specialist Reports to: Quality Assurance Manager Location: Hyderabad Job Type: Full-time About Us: Orbit Code Innovation Pvt.Ltd is a IT company specializing in Software Development: "Specializing in custom software development, mobile app development, and web application development for businesses across various industries." ...

  • Quality Assurance Specialist

    3 days ago

    Hyderabad, Telangana, India OrbitCode Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Title: Quality Assurance SpecialistReports to: Quality Assurance ManagerLocation: HyderabadJob Type: Full-timeAbout Us:Orbit Code Innovation Pvt.Ltd is a IT company specializing in Software Development:"Specializing in custom software development, mobile app development, and web application development for businesses across various industries.""Developing...

  • Training and Quality Assurance

    6 days ago

    Begumpet, Hyderabad, Telangana, India Goldsikka Full time

    **Learn about the key requirements, duties, responsibilities, and skills that should be in a quality assurance specialist job description.** Quality assurance specialists are responsible for monitoring, inspecting, and proposing measures to correct or improve a company's final products and processes in order to meet established quality standards. Quality...

  • Quality Assurance Engineer

    3 days ago

    Hyderabad, Telangana, India Tungsten Automation Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Management and staff in Tungsten Automation's Quality Assurance job family help the company to assure that its products and technology solutions are designed and built in accordance with company standards and customer requirements. The position of Engineer is a core, entry-level departmental role and appointees are expected to perform whole core departmental...

  • Quality Assurance Engineer

    2 weeks ago

    Hyderabad, India Tungsten Automation Full time

    Management and staff in Tungsten Automation's Quality Assurance job family help the company to assure that its products and technology solutions are designed and built in accordance with company standards and customer requirements. The position of Engineer is a core, entry-level departmental role and appointees are expected to perform whole core departmental...

  • Quality Assurance Specialist

    4 days ago

    Hyderabad, India Earthful.me Full time

    About Earthful Earthful is an FMCG company focused in the health and wellness space. The founders (Sudha Gogineni and Veda Gogineni) are graduates from IIT Kharagpur and ISB with a multitude of experience across multinational companies & startups, such as Uber, Meesho, Deutsche Bank, ITC. Earthful is an early stage startup and hence the candidate will have...

  • Quality Assurance Specialist

    2 days ago

    Hyderabad, India Earthful.me Full time

    About EarthfulEarthful is an FMCG company focused in the health and wellness space. The founders (Sudha Gogineni and Veda Gogineni) are graduates from IIT Kharagpur and ISB with a multitude of experience across multinational companies & startups, such as Uber, Meesho, Deutsche Bank, ITC. Earthful is an early stage startup and hence the candidate will have...

  • Quality Assurance Specialist

    3 weeks ago

    Hyderabad, Telangana, India Earthful Full time

    About Earthful Earthful i s an FMCG company focused in the health and wellness space. The founders ( and are graduates from IIT Kharagpur and ISB with a multitude of experience across multinational companies & startups, such as Uber, Meesho, Deutsche Bank, ITC. Earthful is an early stage startup and hence the candidate will have the opportunity to...

  • Engineer Quality Assurance

    3 weeks ago

    Hyderabad, Telangana, India Tungsten Automation Full time

    Job DescriptionManagement and staff in Tungsten Automation&aposs Quality Assurance job family help the company to assure that its products and technology solutions are designed and built in accordance with company standards and customer requirements. The position of Engineer is a core, entry-level departmental role and appointees are expected to perform...

  • Quality Assurance Specialist

    3 weeks ago

    Hyderabad, Telangana, India Earthful Full time

    About Earthful Earthful i s an FMCG company focused in the health and wellness space. The founders (Sudha Gogineni and Veda Gogineni ) are graduates from IIT Kharagpur and ISB with a multitude of experience across multinational companies & startups, such as Uber, Meesho, Deutsche Bank, ITC. Earthful is an early stage startup and hence the candidate...