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Sr. Quality Engineer at Minerva Surgical
Redwood City, CA, US

The Sr. QE is responsible for supporting the development, implementation, and maintenance of quality systems to ensure compliance with EN ISO 13485:2016, CMDR (Canadian Medical Device Regulations), MDD (Medical Device Directive) and FDA QSR working closely with cross-functional departments

DUTIES & RESPONSIBILITIES

  • Manage Corrective & Preventive Action (CAPA)/ Supplier Corrective Action (SCAR) System.
  • Help facilitate Complaint/MDR System. Ensure complaint management activities are conducted in a proper and timely manner, including receipt from the field, investigation receipt and closure. 
  • Work collaboratively with other departments (e.g. R&D, Operations, etc.) on complaint event analyses.
  • Conduct problem solving, root cause investigation, developing action plans, effectiveness checks activities.
  • Help facilitate audits, internal and external. Issue CAPAs/Corrections resulting from such audits.
  • Support supplier evaluation & monitoring activities. Coordinate supplier audits during initial qualification and re-evaluation, review the reports, follow-up issuing SCARs and ensuring SCARs are completed.
  • Collaborate with R&D project teams to support and or process design and development activities.
  • Provide comprehensive review of the Risk Management File, Design History File, Device Master Record and all other deliverables required for each phase per the Design Control system.
  • Help facilitate Returned Goods Analysis (RGA) System.
  • Help facilitate NCR and Deviation Systems.
  • Initiate Engineering Change Orders (ECOs) as necessary. Review ECOs to ensure correct and complete and to detect any compliance issues.
  • Other duties as required to support operation of the quality system.

PREFERRED QUALIFICATIONS:

Preferred Requirements:

  • Knowledge of CAPA/SCAR system.
  • Knowledge of trending and analysis of Quality Data.
  • Coordinate or conduct Supplier Audits.
  • Understands basic statistical data analysis.
  • Proficiency with MS Word, MS Excel, and MS Visio.
  • High level of attention to detail and organization.
  • Proven ability to effectively work cross-functionally at all levels of the organization.
  • Must be able to function in a typical startup environment (fast pace, multi-tasking, tight deadlines).
  • Excellent verbal, written, and presentation communication skills.
  • Understanding of Medical Device Risk management.
  • Working knowledge of current EN ISO 13485:2016, CMDR (Canadian Medical Device Regulations), MDD (Medical Device Directive) and FDA QSR.

Preferred Education and/or Job experience:

  • Bachelor’s degree in Engineering or related technical discipline
  • 5+ years’ experience in a quality role in the medical device industry, preferably with a Class III medical device.
  • Understanding of design controls, risk management, statistical techniques, complaints/MDRs, NCRs/MRB, Deviations, RGAs, CAPAs/SCARs, internal audits, and supplier audits.
  • Preferred Certifications: ASQ Certified Quality Engineer (CQE), ASQ Certified Quality Auditor (CQA), ASQ Certified Biomedical Auditor (CBA).