Quality Assurance Specialist

4 days ago

Crystal Lake, Illinois, United States Accurate Personnel LLC Full time
Quality Engineer Job Description

We are seeking a highly skilled and detail-oriented Quality Engineer to enhance our operational quality systems. This role demands a proactive approach to managing customer complaints, calibration programs, risk management, statistical techniques, and continual improvement initiatives.

The Quality Engineer will play a pivotal role in ensuring compliance with ISO 14971 and other relevant standards, while supporting various audits and training programs.

Key Responsibilities:
  • Customer Complaint Management: Oversight and management of customer complaints to ensure timely and effective resolution.
  • Calibration Program Supervision: Supervision of the calibration program to ensure accuracy and precision of equipment and instruments.
  • Risk Management: Management of the risk management plan and life cycle maintenance, ensuring adherence to ISO 14971.
  • Statistical Techniques: Oversight of statistical techniques, including data analysis and trending for continuous improvement.
  • CAPAs and Corrective Actions: Leading and supporting Corrective and Preventative Actions (CAPAs) to address quality issues.
  • Operational Quality Systems: Development of operational quality systems (processes, procedures, test methods) to ensure compliance and efficiency.
  • Value Stream Change Management: Management of value stream change management (DCRs), engineering change requests (ECRs), validation reviews, and approvals (DOEs/IQ/OQ/PQ).
  • Technical Documentation: Critiquing, evaluating, approving, and preparing technical documentation, justifications, and rationales based on sound scientific or engineering principles.
  • Troubleshooting and Training: Assisting in troubleshooting and finding remedies for escalated operational quality system challenges, providing timely, risk-based, and actionable information to site leadership.
  • Audit Support: Supporting internal, customer, corporate, registrar, supplier, and FDA audits to ensure compliance and continuous improvement.
Requirements:
  • Education: Bachelor's degree in a related field (Engineering, Quality, Business Management)
  • Experience: 3+ years of demonstrated experience in a manufacturing environment.
  • Knowledge and Skills: Knowledge of compliance and processes, strong self-motivation, ability to work independently and within a team environment, excellent attendance record, and ability to work safely and with minimal supervision.
  • Preferred Qualifications: ASQ certification (CSSGB, CQE), experience with IQMS, and practical knowledge of FDA QSR 820, ISO13485, and/or ISO 9000.

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