Job Summary:

We are seeking a detail-oriented Quality Engineer with expertise in plastic injection molding, metrology, and statistical analysis to ensure the highest quality standards for our medical products. 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:

o Develop, implement, and maintain quality control plans and procedures for plastic injection molding processes.

o Conduct thorough inspections and testing of molded components to ensure they meet stringent quality and regulatory standards.

o Investigate and resolve quality issues through root cause analysis and implement corrective and preventive actions (CAPA).

o Perform regular audits of manufacturing processes and quality systems to ensure compliance with medical industry standards.

2. Metrology and Measurement:

o Utilize advanced metrological tools and techniques (e.g., CMM, laser scanners, micrometers) to measure and validate the dimensions and tolerances of molded parts.

o Calibrate and maintain precision measuring equipment, ensuring accurate and reliable measurement data.

o Develop and execute measurement plans and perform complex measurement analysis.

3. Statistical Analysis:

o 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.

o Develop and monitor key quality metrics and performance indicators.

o Generate statistical reports and present findings to stakeholders, recommending actions based on data analysis.

4. Regulatory Compliance:

o Ensure that all quality control processes and products comply with relevant medical device regulations (e.g., FDA, ISO 13485).

o Prepare and review documentation for regulatory submissions and audits.

o Stay abreast of changes in industry regulations and standards, integrating updates into quality practices as needed.

5. Cross-Functional Collaboration:

o Collaborate with engineering, design, and production teams to address quality issues and enhance processes.

o Provide training and guidance on quality control techniques, metrology practices, and statistical analysis to team members.

o Engage with suppliers to ensure the quality of incoming materials and components.

6. Continuous Improvement:

o Identify and implement process improvements to enhance product quality and operational efficiency.

o Participate in Lean Manufacturing initiatives and other continuous improvement projects.

o 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:

o Proficiency in metrological equipment and techniques (e.g., CMM, calipers, micrometers).

o Strong understanding of plastic injection molding processes and quality requirements.

o Advanced knowledge of statistical analysis methods and tools (e.g., SPC, DOE).

o Familiarity with medical device regulations and quality standards (e.g., FDA, ISO 13485).

o Excellent analytical and problem-solving skills, with the ability to interpret complex data and make data-driven decisions.

o Strong communication skills and the ability to collaborate effectively with cross-functional teams.

o 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 essentia

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.