Metrologist/CMM Programmer

We are seeking a highly skilled and experienced Quality Assurance Technician (Level 3) specializing in Metrology to join our team in the medical plastic injection molding industry. In this role, you will play a critical role in ensuring the precision and accuracy of our medical device components through advanced metrology techniques and equipment.




Responsibilities:

• Metrology Expertise: Utilize advanced metrology equipment and techniques to conduct precise measurements and analysis of medical plastic injection molded components, ensuring compliance with tight tolerances and specifications.

• Calibration: Perform calibration and maintenance of metrology equipment, including coordinate measuring machines (CMM), optical comparators, surface roughness testers, and other precision measurement tools, to ensure accuracy and reliability of measurements.

• Inspection Planning: Develop inspection plans and methodologies for complex medical device components, collaborating with engineering and production teams to establish appropriate measurement techniques and tolerances.

• Statistical Analysis: Apply statistical analysis methods, such as statistical process control (SPC) and capability studies, to assess the capability of manufacturing processes and identify opportunities for improvement.

• Root Cause Analysis: Lead investigations into non-conformities and deviations from quality standards, utilizing root cause analysis methodologies to identify underlying causes and implement corrective actions.

• Documentation: Maintain detailed records of metrology activities, inspection results, and calibration records in accordance with regulatory requirements and quality management system (QMS) procedures.

• Training and Mentoring: Provide training and mentorship to junior technicians and production personnel on metrology techniques, equipment operation, and quality assurance principles.

• Compliance: Ensure compliance with relevant regulatory standards and guidelines, including FDA regulations and ISO requirements, by following established metrology procedures and protocols.

• Continuous Improvement: Drive continuous improvement initiatives related to metrology processes, equipment, and methodologies, aiming to enhance efficiency, accuracy, and overall quality within the manufacturing environment.

• Communication: Collaborate effectively with cross-functional teams, including engineering, quality assurance, and production, to communicate metrology-related findings, address quality issues, and drive resolution of problems.

Requirements:

• Education: Bachelor's degree in engineering, metrology, or related field; equivalent combination of education and experience may be considered.

• Experience: Minimum of 3-5 years of experience in metrology, quality assurance, or related roles within the medical device or plastic injection molding industry.

• Metrology Skills: Proficiency in operating advanced metrology equipment, such as CMMs, optical comparators, and surface roughness testers, and interpreting measurement data using metrology software (e.g., PC-DMIS).

• Analytical Skills: Strong analytical and problem-solving skills, with the ability to interpret complex technical drawings, specifications, and geometric dimensioning and tolerancing (GD&T) requirements.

• Regulatory Knowledge: Familiarity with regulatory requirements for medical device manufacturing, including FDA regulations (e.g., 21 CFR Part 820) and ISO standards (e.g., ISO 13485).

• Communication: Excellent verbal and written communication skills, with the ability to communicate technical information effectively to diverse audiences and facilitate collaboration across teams.

• Teamwork: Demonstrated ability to work collaboratively in a cross-functional team environment, fostering a culture of continuous improvement and quality excellence.

• Attention to Detail: Exceptional attention to detail and commitment to ensuring the highest standards of precision, accuracy, and quality in metrology activities.