QA Technician III

Job Description

Job Description

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:

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. Documentation: Maintain detailed records of metrology activities, inspection results, and calibration records in accordance with regulatory requirements and quality management system (QMS) procedures.
7. Training and Mentoring: Provide training and mentorship to junior technicians and production personnel on metrology techniques, equipment operation, and quality assurance principles.
8. Compliance: Ensure compliance with relevant regulatory standards and guidelines, including FDA regulations and ISO requirements, by following established metrology procedures and protocols.
9. 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.
10. 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:

1. Education: Bachelor's degree in engineering, metrology, or related field; equivalent combination of education and experience may be considered.
2. Experience: Minimum of 3-5 years of experience in metrology, quality assurance, or related roles within the medical device or plastic injection molding industry.
3. 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).
4. 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.
5. 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).
6. Communication: Excellent verbal and written communication skills, with the ability to communicate technical information effectively to diverse audiences and facilitate collaboration across teams.
7. Teamwork: Demonstrated ability to work collaboratively in a cross-functional team environment, fostering a culture of continuous improvement and quality excellence.
8. Attention to Detail: Exceptional attention to detail and commitment to ensuring the highest standards of precision, accuracy, and quality in metrology activities.