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Work Location: Pleasanton, CA. This position is required to be onsite during working hours (M-F, 8:00 – 5:00). Working remotely will not be considered.

Job Description:

Mawi DNA Technologies is an emerging biotechnology focused on biosample collection technologies. Our products are being recognized by leading organizations in the pharmaceutical, diagnostics, academic, and government sectors. We are expanding our products into the IVD industry and are seeking a Medical Device Quality Specialist to assist with the quality management system, daily quality tasks, and in operations. This position will report to the CEO and CTO.

Position will start as temp-to-hire but will transition into a full-time, permanent role depending upon performance.

Responsibilities

• Understand and drive the organization’s Quality Management System based on 21 CFR 820 and ISO 13485.
• Managing the following functions:
  • Customer complaints
  • MRB and NCMR
  • Assist with CAPA
  • Oversee incoming inspection and in-process inspection
  • Calibration Program and PM schedule
  • Process Document Control and maintain records
• Managing suppliers:
  • Quality issue, process critical supplier approval, supplier performance metrics, and occasionally conduct supplier audit.
• Assist with internal- as well as external audits.
• Maintain current quality KPM, DM, and Change Control.
• Participate and present quality update/status in quarterly MRM (Management Review Meeting).
• Write procedures, work instructions, and forms.

Qualifications and Skills

• HS Diploma and a minimum of 8 years’ experience in QMS, QSR, and EU-MDR/EU-IVDR.
• FDA cGMP completion of training and ISO 13485 Lead Auditor Certified is a plus but not required.
• Fully understand the requirements for QMS and QSR.
• Good knowledge of Risk Management, FMEA (d/p), IQ,OQ,PQ and process validation.
• Strong time management, organization, technical, and written communication skills.

SALARY: $33 – $38/hr