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Quality Engineer



Quality Assurance
San Francisco, CA, USA
Posted on Friday, February 2, 2024

Primary Responsibilities:

  • Monitor manufacturing process performance quality indicators, carry out supporting analysis / investigations and drive actions / improvements as needed.
  • Monitor product field performance quality indicators, carry out supporting analysis / investigations, and drive actions / improvements as needed.
  • Support Quality Management System processes and ensure any Quality issues are investigated and resolved.
  • Drive Quality Management System continuous improvement. Identify opportunities to maximize efficiency and ensure/promote compliance with company personnel.
  • Evaluate proposed product changes for qualification and validation requirements and assist in change implementation.
  • Support the Design Transfer team in ensuring the product design is successfully translated into production specifications and processes.
  • Work collaboratively with Cytovale Operations and Contract Manufacturing Organizations to:
  • Assist in developing process validation protocols (IQ/OQ/PQ); review and approve validation reports as needed.
  • Assist in developing process FMEA or equivalent production risk assessments.
  • Evaluate and analyze current manufacturing processes to ensure necessary process controls in place.
  • Identify potential manufacturing process improvements that will lead to better quality products and improve yields.
  • Develop and validate new equipment, tools, test methods, and fixtures.
  • Support internal, supplier and 3rd party audits.
  • Provide support to the Engineering and Operations teams with guidance related to quality processes.

Minimum Qualifications:

  • Bachelor’s degree in scientific discipline (e.g. Engineering, Biology, or Medical Devices, etc).
  • 3+ years related experience in the medical device industry.
  • Proficiency with Microsoft Office (e.g., Word, Excel, Project, etc.)
  • Knowledge of regulations and standards such as 21 CFR 820, ISO 13485, ISO 14971, etc.
  • Prior experience with QMS processes such as Document Control, Materials Control, Receiving, CAPAs, NCRs, Training, etc. required.
  • Candidate should have good organizational skills as well as strong written/verbal communications skills.
  • Candidate should be able to prioritize tasks, drive process improvements, demonstrate the ability to think critically and thrive in a fast-paced environment.

Preferred Qualifications:

  • IVD experience
  • Knowledge/experience with microfluidics and plastic injection molding
  • Prior experience with an electronic Quality Management System (eQMS).