Medical Device Quality Assurance Specialist Opportunity

1 day ago

Kottayam, Kerala, India beBeeQuality Full time ₹ 1,80,00,000 - ₹ 2,50,00,000
Job Role:

Medical Device Quality Assurance Specialist

Key Responsibilities:
  • Create a quality culture by driving compliance activities and ensuring regulatory adherence.
  • Represent the company externally and champion quality culture evolution.
  • Organize, drive, and lead successful quality management system processes at a medical device facility.
  • Develop comprehensive procedures, work instructions, and documentation for products and processes.
  • Collaborate with cross-functional teams to improve process efficiency and effectiveness.
  • Ensure quality information accuracy and ask pertinent questions to stakeholders.
  • Offer new solutions to problems and provide recommendations.
Required Qualifications:
  • Minimum of a Bachelor's Degree in a relevant field such as engineering or science.
  • Strong technical communication skills in English (written and oral).
  • Experience in establishing design quality control, assurance, and regulatory affairs teams from scratch within a regulated industry.
  • Understanding and interpretation of risk management, design controls, standards, and regulations for medical devices.
Additional Roles:Technical Expertise:
  • Responsible for developing lab infrastructure, new products, and advanced technology developments.
  • Has in-depth knowledge of best practices and integration with other functional areas.
  • Uses judgment to make decisions or solve moderately complex tasks or problems.
  • Acts as a resource for colleagues and leads small projects.
Required Qualifications:
  • Experience in mechanical engineering, technology, and design engineering management.
  • Masters degree or Bachelors degree in engineering (specialized in mechanical/manufacturing) or physics.
  • Relevant medical device design work experience in new product development.
Other Roles:Electrical & Electronics Engineering:
  • Looking for talents in electrical & electronics hardware engineering, including embedded hardware engineering.
  • Expertise in India and global medical devices design controls, quality management systems, and standards.
  • Lead/contribute to electrical & electronics technical solutions and products.
  • Design, analyze, integrate, and document products, systems, or subsystems.
Software Engineering Role:Key Responsibilities:
  • Execute on the organization's strategy and deliver high-quality software.
  • Focuses on customers by understanding their needs to design and implement solutions.
  • Ensures adherence to development processes, standards, and regulatory requirements.
  • Be a technical subject matter expert in software engineering, including embedded software engineering.
Required Qualifications:
  • Must have relevant skills and experience in software development and engineering.
  • Ability to adapt quickly to changing circumstances and priorities.
Systems Engineering Role:Key Responsibilities:
  • Audit support for products for various regulatory agencies.
  • Customer satisfaction by providing faster engineering resolution to issues faced by customers.
  • Collaborates with system engineering groups and adopts good practices.
  • Develop strategy for knowledge build-up for life cycle management products.
Required Qualifications:
  • Technical degree in systems engineering or related field.
  • Proven track record in managing large-scale projects.
  • Strong communication and interpersonal skills.

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