Quality Assurance Engineer III - Audit SPOC

Thermo Fisher Scientific   •  

Fair Lawn, NJ

Industry: Professional, Scientific & Technical Services

  •  

8 - 10 years

Posted 70 days ago

This job is no longer available.

Responsibilities:

  • This position is responsible for acting as the single point of contact (SPOC) for the audit program at the Fair Lawn and Bridgewater sites. This key technical role is responsible for the scheduling, planning, leading/hosting, response and follow-up for all inspections held at the NJ locations, including customer and regulatory agency inspections.
  • This role includes the management and oversite of the internal audit program for the Fair Lawn and Bridgewater sites per GMP (as applicable) and ISO 9001:2015:

    Key activities of this role include:

    • Generation of the internal audit schedule for both NJ locations
    • Coordinate audit activities with applicable departments
    • Track audit activities and follow-up requirements
    • Work with QA Management to determine acceptance of audit responses
    • Managing, scheduling and hosting of client and regulatory audits/inspections
    • Site Audit preparation activities, including backroom management
    • Work with QA Management to determine acceptance of audit responses and questionnaires
    • Issuance of all responses for customer audit responses
    • QA Owner of any audit related corrective and preventive actions to ensure timely closure of activities.
    • Responsible for the management/periodic review of the Self-audit Questionnaire
  • Responsible to support ISO certification and recertification activities
  • Assures Quality System (QS) compliance with FDA Quality System Regulation (QSR) (as applicable) and International Standards Organization (ISO) regulations as Audit SPOC.
  • Participates in PPI / Kaizen events as key Quality SME.
  • Partners with the senior Quality management and Operations leads for implementation of quality system improvements needed to be driven at the local site as part of the responses to internal, customer, agency inspections.

Qualifications:

  • Bachelor’s degree in Biological Sciences, Engineering or related field, or equivalent combination of education and work-related experience.
  • ISO Lead auditor certification and Certified Quality Auditor (CQA) highly preferred.
  • 8+ years relevant industry experience.
  • Knowledge of US and International regulations and standards that apply to the medical device industry including FDA Quality Systems Regulations (21 CFR 820), Medical Device Reporting (21 CFR 803) Corrections and Removals (21 CFR 806), MDR/IVDR, 13485:2016, ISO 9001: 2015.
  • Must demonstrate effective influencing and change management skills and demonstrated achievements in process improvements.
  • Excellent communication skills at all levels both written and verbal.

85406BR