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Quality Assurance Engineer

Company: BiVACOR Inc
Location: Cerritos
Posted on: November 12, 2021

Job Description:

BiVACOR is seeking an experienced Quality Assurance Engineer (QAE) with a background in manufacturing to join our international team.
The QAE is responsible for reviewing and analyzing data, performing root cause investigations to establish corrective action plans and implement corrective actions, developing and performing test methods for product inspections, testing and investigations, writing and updating procedures as required to ensure the quality system is compliant with regulations including the FDA Quality System Requirements (QSR), ISO 13485 and 21 CFR 820.
The QAE will work with internal engineering staff from mechanical and electrical engineering backgrounds to the support manufacturing planning. The QAE will act as a liaison between the company and external vendors/suppliers to ensure QA activities are sufficiently undertaken to support product development.
The role requires the QAE to work at the BiVACOR Engineering Office at Cerritos, California.
Responsibilities

  • Review and analyze data, performing root-cause investigations to establish corrective action plans and implement corrective actions, developing and performing test methods for product inspections, testing and investigations, writing and updating procedures as required to ensure the quality system is compliant with regulations.
  • Maintain detailed reports related to supplier quality - report on supplier quality status and drive changes in vendor/supplier processes.
  • Reviewing incoming products from vendors/suppliers and identify flaws and issues with quality.
  • Review and assess supplier processes.
  • Conducts assessments/ tests on batches of products to identify recurring errors or quality issues
  • Provide technical guidance and advice to internal team and suppliers regarding quality improvements.
  • Track and report quality metrics.
  • Coordinate the documentation review, inspection workflow, training, problem solving and calibration for medical products and test equipment.
  • Participates in the non-conformance reporting system, driving timely disposition and closure. Identify non-conformance trends and develop and administer technical investigation and corrective action programs to resolve recurring quality problems
    Requirements
    • Minimum 5 years' experience as a Quality Engineer in the medical device industry
    • Bachelor's degree or higher in Engineering or similar
    • Medical Device Quality System knowledge including 21 CFR Part 820 (QSR) & ISO 13485
    • Experience with CAPA, complaint investigation, field action processes and risk management.
    • Individual must have a hands-on approach
    • Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports; and give oral presentations
    • Detailed knowledge in manufacturing processes and engineering principles to make informed judgments and recommendations.
    • Experience with electrical/mechanical systems for medical devices in a regulated environment.
    • Excellent written and verbal communication skills to serve as liaisons between companies and suppliers and prepare quality assurance reports
    • Experience in medical design controls, including design (customer and product) requirements, performance specifications, and verification and validation testing

Keywords: BiVACOR Inc, Cerritos , Quality Assurance Engineer, Engineering , Cerritos, California

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