Quality Assurance Engineer II

2 weeks ago


San Francisco, California, United States The Ladders Full time
Position Overview:
As a Quality Assurance Engineer II, you will play a pivotal role within the Quality Assurance division, focusing on enhancing process and product quality metrics, ensuring the effectiveness of the quality management system, and facilitating design transfer and process validation initiatives with our contract manufacturers. Your contributions will be vital in driving manufacturing process enhancements.

Key Responsibilities:
  • Collaborate with cross-functional teams on new product development and modifications to design/process control. Assess proposed changes for qualification and validation needs, and assist in the implementation of these changes.
  • Support the Design Transfer team to guarantee that product designs are accurately converted into production specifications and procedures.
  • Serve as the primary quality liaison with contract manufacturers, addressing issues and recommending enhancements.
  • Participate in Risk Management efforts, including risk assessments, DFMEA, and PFMEA.
  • Aid in the upkeep of the Design History File (DHF) and Device Master Record (DMR).
  • Work in partnership with Operations and Contract Manufacturing Organizations to:

    • Track quality performance metrics and initiate corrective/preventive actions.

    • Assist in process validation (IQ/OQ/PQ); review and endorse validation documentation.

    • Analyze manufacturing processes to ensure adequate process controls are established and identify potential improvements.

    • Support the development of new equipment, tools, testing methods, and fixtures.
  • Monitor product field performance quality metrics, conduct supporting analyses/investigations, and drive necessary actions/improvements.
  • Facilitate internal, supplier, and third-party audits.
  • Promote continuous improvement within the Quality Management System. Identify opportunities to enhance efficiency and ensure compliance with company standards.
Qualifications:
  • Bachelor’s degree in a relevant scientific field (e.g., Engineering, Life Sciences).
  • Minimum of 3 years of relevant experience in the medical device sector.
  • Proficient in Microsoft Office applications (e.g., Word, Excel, Project).
  • Familiarity with regulations and standards such as 21 CFR 820, ISO 13485, ISO 14971.
  • Prior experience with Quality Management System processes including Document Control, Materials Control, Receiving, CAPAs, NCRs, and Training.
  • Strong organizational abilities along with excellent written and verbal communication skills.
Requirements:
  • This role offers a hybrid work arrangement.
  • Must be eligible to work in the United States.
  • Willingness to travel domestically up to 15%.


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