Quality Engineer

3 weeks ago


Lowell, United States Lumicity Full time

Please apply or send your resume to klelix.hamlin@lumicity.io

The Quality Engineer is responsible for overseeing the quality assurance of medical devices, from initial design through manufacturing and post-market surveillance. This role ensures that all products are manufactured in compliance with ISO 13485, FDA, and other regulatory standards.

Essential Duties and Responsibilities:

  • Quality System Management:
  • Maintain and improve the Quality Management System (QMS) in accordance with ISO 13485 and FDA regulations.
  • Participate in internal and external audits, including preparing necessary documentation and follow-up on corrective actions.
  • Validation and Verification:
  • Design and execute validation protocols for new products and processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Ensure all manufacturing processes, equipment, and materials meet pre-set quality standards.
  • Risk Management:
  • Conduct risk analysis and management throughout the product lifecycle in accordance with ISO 14971.
  • Prepare and maintain Risk Management Files (RMF) for all products.
  • Product Quality Assurance:
  • Perform root cause analysis on product failures and implement corrective and preventive actions (CAPA).
  • Review and approve product testing methods and final product releases.
  • Supplier Quality Management:
  • Work with suppliers to establish quality requirements for materials, components, and sub-assemblies.
  • Conduct supplier audits and performance evaluations to ensure compliance with quality standards.
  • Documentation and Reporting:
  • Develop and maintain comprehensive documentation for quality assurance processes and procedures.
  • Generate quality reports for management review, including trend analysis and quality performance metrics.
  • Training and Leadership:
  • Train and support production staff on quality assurance standards and practices.
  • Lead cross-functional teams to address and resolve quality issues.

Qualifications:

  • Bachelors degree in Engineering, Quality, or a related field.
  • 3+ years of experience in quality engineering within the medical device industry.
  • Strong understanding of FDA, ISO 13485, and other regulatory standards.
  • Proficiency in statistical analysis software and Microsoft Office Suite.
  • Excellent communication and interpersonal skills.
  • Strong analytical and problem-solving abilities.

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