Medical Device Quality Engineer

1 week ago

San Francisco, California, United States Safeguard Global Recruiting Full time
Job Description

Safeguard Global Recruiting is seeking a highly skilled Quality Engineer to join our team. As a Quality Engineer, you will play a critical role in ensuring the quality and reliability of our medical devices.

Key Responsibilities
  • Quality Integration: Integrate quality into manufacturing processes as a value-added support function, performing root cause analysis, driving data-based continuous quality improvements, and building strong customer relationships.
  • Regulatory Compliance: Ensure the successful integration of quality assurance, risk mitigation, and regulatory compliance into device design, development, and manufacturing processes throughout the product lifecycle.
  • Design Control: Participate in design control and evaluate changes to design and/or manufacturing process for impact to DHF. Lead and execute activities to close any gaps, such as additional verification testing or updates to risk documentation.
  • Risk Assessment: Assist with product and process risk assessment activities, including hazard analysis and design/process failure modes & effects analysis (DFMEA/PFMEA).
  • Product Qualification: Participate in product and process qualification and evaluation activities, not limited to but including complaint investigation, first article, engineering studies, gage R&R, regression analysis, SPC, and DOE.
  • Quality Development: Develop and implement methods for sampling, inspection, defect recognition, product testing and evaluation, and SPC trending utilizing statistical, engineering, and quality knowledge.
  • Investigation and Audits: Support the timely handling of investigations, risk assessments, deviations, NCRs, and CAPAs. Support internal and external audits as a device and QMS Subject Matter Expert.
  • Leadership and Mentoring: Leadership and mentoring responsibility for promoting and implementing best-in-class Quality Management Systems, manufacturing processes, statistical techniques, and QMS software solutions.
Qualifications
  • Experience: Minimum 3-5 years' experience in a quality engineering role in the medical device industry, or a related industry with manufacturing & assembly processes.
  • Communication Skills: Excellent written and verbal communication skills.
  • Technical Skills: Proficiency with standard office productivity suite and data analysis software, LMS, and eQMS software familiarity is a plus.
  • Certifications: ASQ CQE preferred.
  • Knowledge: High level of competence in statistical techniques, control charts, sampling plans, quality costs, design of experiments, correlation, regression, analysis of variance, probability, etc.
  • Regulatory Knowledge: Experience in medical device design control, risk management, validation, and product lifecycle. Experience with FDA GMP practices, CAPA, and non-conforming material processes. Working knowledge and application of device regulations, including 21 CFR 820, ISO 13485, and ISO Knowledge of MDSAP, EU MDD/MDR a plus.
  • Leadership Skills: Ability to manage multiple projects within various disciplines, in a fast-paced environment. Self-motivated and capable of working cross-functionally with minimal supervision.
  • Technical Guidance: Demonstrated ability to assess and provide technical, statistical, and quality guidance throughout the organization to ensure high-quality, compliant products.
  • Interpersonal Skills: Must be detail-oriented with strong leadership skills and excellent interpersonal, collaboration, and communication skills.

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