Senior Quality Assurance Engineer for Medical Devices

6 days ago


Torrington, Connecticut, United States GPAC Full time

**Job Overview**

We are seeking a skilled Senior Quality Assurance Engineer to join our team at GPAC. As a key member of our quality assurance department, you will play a critical role in ensuring the highest quality standards for medical devices.

Salary Range: $90,000 - $120,000 per year

**Job Description**

The successful candidate will have expertise in plastic injection molding, metrology, and statistical analysis. They will be responsible for developing and maintaining quality control plans for injection molding processes, conducting thorough inspections, and implementing corrective actions.

Key Responsibilities:

  • Quality Control & Assurance: Develop and maintain quality control plans for injection molding processes, conduct thorough inspections, investigate issues using root cause analysis, and implement corrective actions.
  • Metrology & Measurement: Use advanced tools like CMM, laser scanners, and micrometers for precision measurement, calibrate equipment, execute measurement plans, and analyze complex data to validate part dimensions and tolerances.
  • Statistical Analysis: Apply statistical methods (SPC, DOE) to assess data, identify trends, and recommend improvements, monitor quality metrics, generate reports, and advise stakeholders based on data insights.
  • Regulatory Compliance: Ensure compliance with medical device regulations (FDA, ISO 13485), prepare documentation for audits, and stay updated on regulatory changes to integrate into quality practices.
  • Collaboration & Training: Work with engineering, design, and production teams to address quality issues and enhance processes, provide guidance on quality control, metrology, and statistical methods to team members and suppliers.

Required Skills and Qualifications:

  • Education: Bachelor's degree in Mechanical Engineering, Industrial Engineering, Statistics, or a related field; Six Sigma or ASQ certification preferred.
  • Experience: 3-5 years in quality engineering, with specific experience in injection molding, metrology, and statistical analysis, preferably in the medical device industry.
  • Skills:
    • Proficiency in metrological tools (CMM, calipers, micrometers)
    • Knowledge of plastic injection molding processes and requirements
    • Strong grasp of statistical analysis tools (SPC, DOE)
    • Familiarity with FDA and ISO 13485 standards
    • Excellent analytical, problem-solving, and communication skills


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