TekOne IT Services Pvt. Ltd.

Quality Engineer

TekOne IT Services Pvt. Ltd. 美国 康乃狄克州 塞莫尔
TekOne IT Services Pvt. Ltd.

Quality Engineer

TekOne IT Services Pvt. Ltd. 美国 康乃狄克州 塞莫尔
1 个月前
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Job title: Quality Engineer

Location: Southington, CT

Duration : 12+ Months

Industry: Pharma

Key Responsibilities

  • Quality Systems Management: Maintain and improve the Quality Management System (QMS) to ensure compliance with ISO 13485, 21 CFR Part 820, FDA regulations, and other applicable standards.
  • Product Development Support: Collaborate with the R&D and manufacturing teams to ensure quality is integrated into the product design and development process.
  • Process Validation: Oversee validation activities for manufacturing processes, equipment, and software, ensuring compliance with validation protocols such as IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
  • Risk Management: Conduct risk analysis and manage the risk assessment process (e.g., FMEA) to identify and mitigate potential quality issues in product development and production.
  • CAPA (Corrective and Preventive Actions): Lead and participate in the CAPA process to address non-conformances, deviations, and other quality-related issues, ensuring root cause analysis and effective corrective actions are implemented.
  • Internal & Supplier Audits: Conduct and participate in internal audits and external supplier audits to ensure compliance with quality and regulatory standards.
  • Non-Conformance Management: Investigate non-conforming products and materials, perform root cause analysis, and implement corrective and preventive actions to prevent recurrence.
  • Documentation & Reporting: Maintain accurate quality records, including inspection reports, validation documents, and regulatory submissions. Ensure documentation complies with QMS requirements.
  • Continuous Improvement: Drive continuous improvement initiatives to enhance product quality, reduce defects, and improve manufacturing processes.
  • Complaint Handling: Assist in the investigation of customer complaints and product returns, ensuring timely resolution and reporting of issues to regulatory authorities as required.
  • Regulatory Compliance: Ensure all products and processes meet relevant medical device regulations, including FDA, EU MDR, and other global standards.
  • Supplier Quality Management: Work with suppliers to ensure that incoming materials meet specified quality standards. Conduct supplier quality audits and manage supplier performance.

Required Qualifications

  • Education:
    • Bachelor’s degree in Engineering, Biomedical Engineering, Quality Engineering, or a related technical field.
    • Certifications such as Certified Quality Engineer (CQE) or Six Sigma (Green Belt or Black Belt) are a plus.
  • Experience:
    • 3-5 years of experience in a quality engineering role within the medical device industry.
    • Proven experience working with ISO 13485, FDA regulations (21 CFR Part 820), and other regulatory standards in the medical device field.
  • Technical Skills:
    • Experience with validation protocols (IQ, OQ, PQ) and process validation in a regulated environment.
    • Proficiency in quality tools and methodologies, such as Root Cause Analysis (RCA), FMEA, SPC, and CAPA.
    • Strong understanding of GMP (Good Manufacturing Practices) and risk management principles.

  • 职位级别

    中高级

  • 职位性质

    全职

  • 职能类别

    质检

  • 所属行业

    人力资源服务

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