Current jobs related to Quality Assurance Manager - Thāne, Maharashtra - Biovantage Technology Solutions

  • Quality Assurance Manager

    2 weeks ago

    Thāne, Maharashtra, India beBeeQuality Full time ₹ 30,00,000 - ₹ 50,00,000

    Job DescriptionWe are seeking an experienced Quality Assurance Manager to oversee the development lifecycle and ensure adherence to regulatory standards and industry best practices.Key Responsibilities:Develop and implement quality assurance strategies and processes, ensuring compliance with regulatory requirements.Collaborate with cross-functional teams to...

  • Quality Assurance Professional

    2 weeks ago

    Thāne, Maharashtra, India beBeeQuality Full time ₹ 10,00,000 - ₹ 12,50,000

    Job Overview:We seek an experienced Quality Assurance Specialist with a strong commitment to quality standards.The ideal candidate is highly organized, methodical and has the experience necessary to take our deliverables to the next level in terms of accuracy and customer satisfaction.Main Responsibilities:Plan, execute and perform inspection and testing of...

  • Sales Performance Management Quality Assurance Expert

    1 week ago

    Thāne, Maharashtra, India beBeeSoftwareTesting Full time ₹ 60,00,000 - ₹ 1,20,00,000

    Quality Assurance EngineerAt the forefront of sales performance management, we seek an accomplished Quality Assurance Engineer to join our team. As a trusted partner in delivering top-tier software consulting solutions, we specialize in implementing cutting-edge technologies and optimizing sales operations.This is a pivotal role in ensuring the highest...

  • Quality Assurance Specialist

    2 weeks ago

    Thāne, Maharashtra, India beBeeSoftware Full time ₹ 12,00,000 - ₹ 20,00,000

    Job Title: Quality Assurance Specialist Role Overview:This is a full-time hybrid position for a Quality Assurance Specialist located in Bengaluru, with some work-from-home flexibility. The Quality Assurance Specialist will be responsible for executing test plans, conducting manual testing, and ensuring the quality of software.Daily tasks include creating,...

  • Senior Manager Quality Assurance and Control

    2 weeks ago

    Thāne, Maharashtra, India beBeeQuality Full time ₹ 15,00,000 - ₹ 25,00,000

    Production and Quality Assurance ManagerAs a seasoned Production and Quality Assurance Manager, you will oversee the quality control processes for a large caliber ammunition manufacturing plant. Your expertise will be crucial in ensuring that all aspects of production adhere to stringent quality standards, from raw materials to finished products.Key...

  • Senior Quality Assurance

    1 week ago

    Thāne, Maharashtra, India Universal HR Solutions Full time ₹ 12,00,000 - ₹ 28,00,000 per year

    We Are Hiring A Senior Quality Assurance (QA) Manager – Systems (Electrical Engineer)Position: Senior Quality Assurance (QA) Manager – Systems (Electrical Engineer)Location: Mumbai (Full-time, Project Site) (Powai Metro)Project: Metro Rail – 66kV & above GIS Substations, Power Supply & E&M SystemsCTC: Minimum Rs.12.00 LPA (Retired Indian Railways...

  • Quality Assurance Specialist

    2 weeks ago

    Thāne, Maharashtra, India beBeeQuality Full time ₹ 20,000 - ₹ 25,000

    Job Title: Quality Assurance SpecialistAbout the RoleThe Quality Assurance Specialist is responsible for ensuring that all products meet established quality standards by inspecting, testing, and monitoring processes at various stages of production.This is an offline job with 6 days working.Key ResponsibilitiesInspect and test raw materials, in-process...

  • Quality Assurance Specialist

    2 weeks ago

    Thāne, Maharashtra, India beBeeQuality Full time ₹ 5,00,000 - ₹ 10,00,000

    Job Title: Quality Assurance SpecialistThe primary function of the Quality Assurance Specialist is to conduct thorough evaluations and assessments of our associates who interact with customers. This role requires a keen eye for detail, exceptional communication skills, and the ability to identify areas for improvement.Key Responsibilities:- Conduct quality...

  • Senior Quality Assurance and Release Manager

    2 weeks ago

    Thāne, Maharashtra, India beBeeRelease Full time ₹ 9,00,000 - ₹ 12,50,000

    Job Title: Senior Quality Assurance and Release ManagerWe are seeking a highly skilled and experienced professional to drive the quality and timely release of our products.Main Responsibilities:Develop and implement comprehensive testing procedures to ensure high-quality releases.Select and implement test automation tools and strategies to improve...

  • Quality Assurance Specialist

    1 week ago

    Thāne, Maharashtra, India beBeeQuality Full time ₹ 8,00,000 - ₹ 12,00,000

    Job Title: Quality Assurance SpecialistWe are seeking a skilled Quality Assurance Specialist to perform audits and assessments of performance, ensuring adherence to company policies and procedures.Conduct thorough quality assurance audits or phone calls to evaluate the quality of performance.Monitor inbound and outbound calls and emails to guarantee...

Quality Assurance Manager

2 weeks ago

Thāne, Maharashtra, India Biovantage Technology Solutions Full time ₹ 15,00,000 - ₹ 20,00,000 per year

We are currently seeking a talented Lead Software Quality Assurance Engineer to join our dynamic team. The ideal candidate will have extensive experience in system engineering, requirement management, risk management, verification and validation, navigating the cybersecurity guidance, as well as a deep understanding of the medical device industry.

Job Title: Manager QA.

Experience: 1015 years in Quality Assurance, with at least 5 years in a leadership or managerial role in the medical device industry.

Qualification:

  • Bachelor's or master's degree in engineering, Life Sciences, Quality Management, or related field.
  • Certifications such as Internal/Lead Auditor ISO 13485, CQA (Certified Quality Auditor)

Job Description:

We are seeking an experienced and dynamic QA Manager to lead our Quality Assurance team and ensure compliance with regulatory and quality standards in the design, development, and manufacturing of medical devices. The QA Manager will be responsible for implementing and maintaining an effective Quality Management System (QMS), driving continuous improvement, and supporting cross-functional teams to achieve high-quality products aligned with global regulatory requirements.

Responsibilities

  • Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, MDR, and other applicable regulations.
  • Lead internal and external audits, including FDA, ISO, notified body, and customer audits.
  • Ensure effective CAPA, NCR, change control, and deviation management processes.
  • Oversee document control, records management, and quality assurance reviews.
  • Establish and monitor quality objectives, KPIs, and continuous improvement initiatives.
  • Manage supplier quality audits, vendor qualifications, and incoming inspection processes.
  • Collaborate with R&D, Regulatory, Manufacturing, and V&V teams to ensure compliance during product development lifecycle and design transfer.
  • Train, mentor, and lead the QA team to strengthen organizational quality culture.
  • Ensure effective risk management in accordance with ISO 14971.
  • Drive initiatives for process validation, software validation, and equipment qualification.
  • Provide management with regular updates on quality system performance and improvement opportunities.

Required Skills:

  • Strong knowledge of ISO 13485, FDA QSR (21 CFR 820), EU MDR, and other applicable global regulations.
  • Hands-on experience with audits (internal, external, regulatory, supplier).
  • Proven expertise in CAPA, risk management, process validation, and complaint handling.
  • Proficiency in quality tools (Root Cause Analysis, Six Sigma, FMEA, SPC, etc.).
  • Excellent leadership, team management, and communication skills.
  • Strong analytical, problem-solving, and decision-making abilities.
  • Proficiency in documentation, reporting, and use of electronic QMS tools.

Preferred Skills:

  • Experience with SaMD (Software as a Medical Device) or IoT-enabled medical devices.
  • Knowledge of ISO 27001, IEC software), IEC safety), and cybersecurity standards.
  • Experience in working with global regulatory bodies (FDA, EU Notified Bodies, TGA, PMDA, etc.).
  • Lean Six Sigma Green Belt/Black Belt certification.
  • Prior experience in supporting regulatory submissions and technical documentation (Design Dossier/Technical File).

Location:

Thane (West), Mumbai