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Senior Quality Assurance Architect for Medical Devices

1 month ago

Pune, Maharashtra, India Philips Full time

We are seeking an experienced Senior Quality Assurance Architect for Medical Devices to join our team at Philips.

Job Description:

The successful candidate will be responsible for ensuring the quality and safety of our medical devices through effective test and verification strategies. This role requires a strong understanding of quality management systems, risk-based testing, and design for manufacturability.

Key Responsibilities:

  • Develop and implement comprehensive test plans to ensure product quality and compliance with regulatory requirements
  • Collaborate with cross-functional teams to identify and mitigate risks associated with new products or technologies
  • Design and implement efficient test automation frameworks to reduce manual testing efforts
  • Conduct regular audits and assessments to ensure compliance with company standards and regulatory requirements
  • Provide guidance and support to junior staff members on quality-related matters

Requirements:

  • Masters or Bachelor's degree in Electronics/ Electrical Engineering or related field
  • At least 15 years of experience in quality assurance, with a minimum of 8 years as a Test and Verification lead/architect in an industrial product R&D environment
  • Experience working in a regulated environment, preferably in the medical device industry
  • Strong knowledge of quality management systems, including ISO 13485 and FDA regulations
  • Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams
  • Proven track record of improving quality and reducing costs through process improvements and efficiency gains

About the Role:

This is an exciting opportunity to join a leading healthcare technology company and contribute to the development of innovative medical devices that improve patient outcomes. As a Senior Quality Assurance Architect, you will have the opportunity to work with a talented team of engineers and scientists to design and develop cutting-edge products.

Salary: The estimated salary for this role is $120,000 - $150,000 per year, depending on experience and qualifications.