Quality Engineer

Position: Quality Engineer
Location: Torrington, CT
Compensation: $85,000.00-$98,000.00- depending on experience
*Company also offers bi-annual target bonus?

We are seeking a detail-oriented Quality Engineer with expertise in? metrology, and statistical analysis to ensure the highest quality standards. The ideal candidate will have a strong background in quality control, experience with advanced measurement techniques, and proficiency in statistical methods to drive continuous improvement and regulatory compliance.
Key Responsibilities:

1. Quality Control and Assurance:
   • Develop, implement, and maintain quality control plans and procedures for plastic injection molding processes.
   • Conduct thorough inspections and testing of molded components to ensure they meet stringent quality and regulatory standards.
   • Investigate and resolve quality issues through root cause analysis and implement corrective and preventive actions (CAPA).
   • Perform regular audits of manufacturing processes and quality systems to ensure compliance with medical industry standards.
2. Metrology and Measurement:
   • Utilize advanced metrological tools and techniques (e.g., CMM, laser scanners, micrometers) to measure and validate the dimensions and tolerances of molded parts.
   • Calibrate and maintain precision measuring equipment, ensuring accurate and reliable measurement data.
   • Develop and execute measurement plans and perform complex measurement analysis.
3. Statistical Analysis:
   • Apply statistical methods (e.g., Statistical Process Control (SPC), Design of Experiments (DOE), hypothesis testing) to analyze data and identify trends, variations, and areas for improvement.
   • Develop and monitor key quality metrics and performance indicators.
   • Generate statistical reports and present findings to stakeholders, recommending actions based on data analysis.
4. Regulatory Compliance:
   • Ensure that all quality control processes and products comply with relevant medical device regulations (e.g., FDA, ISO 13485).
   • Prepare and review documentation for regulatory submissions and audits.
   • Stay abreast of changes in industry regulations and standards, integrating updates into quality practices as needed.
5. Cross-Functional Collaboration:
   • Collaborate with engineering, design, and production teams to address quality issues and enhance processes.
   • Provide training and guidance on quality control techniques, metrology practices, and statistical analysis to team members.
   • Engage with suppliers to ensure the quality of incoming materials and components.
6. Continuous Improvement:
   • Identify and implement process improvements to enhance product quality and operational efficiency.
   • Participate in Lean Manufacturing initiatives and other continuous improvement projects.
   • Track and analyze quality performance metrics to drive ongoing improvements.

Qualifications:

• Education: Bachelor?s degree in mechanical engineering, Industrial Engineering, Statistics, or a related field. Advanced degree or relevant certifications (e.g., Six Sigma, ASQ) is advantageous.
• Experience: Minimum of 3-5 years of experience in quality engineering, particularly with plastic injection molding, metrology, and statistical analysis. Experience in the medical device industry is highly desirable.
• Skills:
  • Proficiency in metrological equipment and techniques (e.g., CMM, calipers, micrometers).
  • Strong understanding of plastic injection molding processes and quality requirements.
  • Advanced knowledge of statistical analysis methods and tools (e.g., SPC, DOE).
  • Familiarity with medical device regulations and quality standards (e.g., FDA, ISO 13485).
  • Excellent analytical and problem-solving skills, with the ability to interpret complex data and make data-driven decisions.
  • Strong communication skills and the ability to collaborate effectively with cross-functional teams.
  • Proficiency in quality management software and statistical analysis tools.

Working Conditions:

• Office and manufacturing environment.
• May involve occasional travel to supplier sites or other company locations.
• Adherence to safety protocols and industry regulations is essential.

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