At Luma Therapeutics, you will have direct responsibility for implementation and maintenance of the Quality Management System, including product development, commercial / production, and complaint handling / CAPA.  You have solid working knowledge of applicable regulations and standards, demonstrated creative and collaborative problem solving skills within the regulated field, have excellent task and time management skills, and thrive in a fast-paced environment with a range of activities from day to day.  Ideally, you have experience in an entrepreneurial / start-up environment.

  • Create, review, and release Engineering Change Orders (ECO).
  • Maintain list of current External Standards and system for revision notification.
  • Ensure compliance of document control practice and ECO approval process with internal procedures, QSR, ISO/EN requirements.
  • Develop archive system to maintain DMR and DHR files.
  • Maintain company training records and provide timely notifications for training.
  • Maintain the part numbering system.
  • Manage input of controlled artwork and packaging labels into Manufacturing.
  • Coordinate the initiation and timely resolution of Non-Conformance Reports.
  • Ensure quality records, production documents, and calibration is accurate and compliant to internal procedures and GMP/GDP
  • Complete incoming and production quality control activities to ensure compliance with internal procedures, QSR, MDD, ISO/EN requirements.
  • Support production quality control activities to ensure timely inspections and efficient material movement. Includes verifying sub-assembly and device history records for completeness

Minimum Qualifications:

  • Education:  Bachelor’s Degree in Engineering or Technical Field
  • Language:  Fluency in spoken and written English
  • 2 years of medical device Quality Assurance experience
  • Deep working knowledge of and experience in Medical Device Quality Management Systems:  FDA QSR, ISO 13485

Preferred Qualifications:

  • 5+ years in medical device Quality Assurance
  • Product Quality support experience

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