Regulatory Compliance Specialist

3 weeks ago


Irvine, California, United States SysMind Tech Full time

We are looking for a highly skilled Regulatory Compliance Specialist to join our team at SysMind Tech.

The estimated salary for this position is $110,000 - $140,000 per year, depending on experience.

The Job Description:

  • Monitor and analyze supplier performance metrics, identify areas of opportunity, communicate supplier risks, and drive the resolution of supplier quality issues and risk control processes.
  • Apply appropriate Quality Engineering and PEx tools (e.g. PM/VSM, Kaizen, DMAIC, FMEA/FTA, RCA, MSA, SPC, Cp/Cpk/Cpm/Ppk, Hypothesis Testing, ANOVA/DOE/EVOP, etc.) to support innovations and continuous improvements.
  • Comply with all applicable quality management system, environmental, safety and occupational health policies (for example, ISO 13485, ISO14001 & OSHAS18001).

Required Skills and Qualifications:

  • A minimum of 8+ years of related experience in Medical Device Supplier Quality domain.
  • Working knowledge of regulatory compliance requirements (i.e. Quality System Regulations (QSRs), Medical Device Directive (MDD), ISO 9001, ISO 13485, ISO 14971 or other international standards).
  • Proven track record of successfully implementing quality initiatives.


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