Quality Engineer - Gpac

Job Summary:We are seeking a Quality Engineer with expertise in plastic injection molding, metrology, and statistical analysis to ensure top-quality standards for medical products. The ideal candidate will have strong quality control experience, advanced measurement skills, and proficiency in statistical methods to drive regulatory compliance and continuous improvement.

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. Perform regular audits to ensure compliance with medical standards.

• 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.

• Continuous Improvement:Lead process improvements, participate in Lean initiatives, and track quality metrics to support ongoing efficiency and product quality enhancements.

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

Work Environment:Office and manufacturing environment; occasional travel may be required. Compliance with safety and industry regulations is essential.

Only the most qualified applicants who provide a resume will be contacted. If you would like to learn more about Manufacturing opportunities, contact Tyler Broekhuis with gpac. Resumes can be confidentially sent to tyler.broekhuis@gogpac.com

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All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.

GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States since 1990. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.