Senior Medical Device Quality Engineer

3 days ago

Bengaluru, Karnataka, India beBeeQuality Full time US$ 1,20,000 - US$ 1,75,000

Job Overview:

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This is a role for an experienced quality engineer who will be responsible for supporting the development and maintenance of medical devices. The ideal candidate will have a strong understanding of design control principles, risk management, and regulatory requirements.

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Main Responsibilities:

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  • Support design control projects">
  • Lead risk management activities">
  • Develop specifications, design, and test methods for new products">
  • Translate customer needs into engineering requirements">
  • Write detailed technical reports based on design verification analysis/testing">
  • Interface with manufacturing to ensure manufacturability of design solutions">
  • Apply technical principles, theories, concepts, and quality sciences/tools">
  • Ensure that all design control and production/process control projects meet applicable regulatory, corporate, and unit requirements">
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Requirements:

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  • Bachelor's degree in engineering or related discipline">
  • A minimum of 8 years meaningful experience or equivalent education/proven experience">
  • Good working knowledge and auditing experience of medical device regulations and practices (ISO13485, ISO 14971, FDA, 21CFR820 Quality System Regulation)">
  • Fair understanding of QA principles, concepts, industry practices, and standards">
  • Extensive knowledge in Design Control principles">
  • Experience in Risk management activities">
  • Proven understanding of statistical concepts such as measurement system analysis, Gage R&R, and validation">
  • Applied knowledge of applicable regulatory, corporate, and/or unit requirements">
  • Experience in design of experiments and statistics">
  • Class II/III medical device experience">
  • Knowledge of six sigma methodology">
  • ASQ certified quality engineer (CQE) or certified quality auditor (CQA)">
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About Us:

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We are a global medical technology company that advances the world of health by improving medical discovery, diagnostics, and the delivery of care.

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Contact Information:

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Please note that we do not provide contact information for this role.

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