The Quality Technician II tests and inspects products in various stages of the validation and production process. The successful candidate will work closely with quality, design, and manufacturing engineering teams throughout product and process validation activities providing metrology support as needed and verify that in-process and finished products which do not conform to specified requirements are prevented from being used or delivered. Will maintain appropriate records to complete evidence of conformance by performing the following essential functions and basic duties.
ESSENTIAL FUNCTIONS AND DUTIES:

General:

• Follow Employee guidelines and Quality System Regulations as defined by Nissha Medical Technologies practices, policies and Standard Operating Procedures to ensure that customer requirements and industry standards and or regulations are met.
• Demonstrates knowledge and acts in accordance with NMT’s Employee Guidelines and applicable quality standards as outlined in NMT’s Quality Manual.
• Abides by all safety and security rules set forth by the company and regulatory agencies
• Regular attendance is required.

Technical:

• Along with the Metrology/QC Supervisor, reviews drawing requirements to determine appropriate measurement methods.
• Analyze GD&T and perform GR&R studies.
• Conducts visual and dimensional studies as assigned.
• Completes assigned metrology tasks according to established project schedules.
• Communicates with engineering, quality, manufacturing, and project management on task delays and measurement issues.
• Assists engineers with data analysis using statistical techniques.
• Responsible for ensuring that in-process and finished products which do not conform to specified requirements are prevented from being used or delivered.

Additional Tasks:

• Responsible for performing and documenting in-process audits in production areas.
• Maintenance of Material Review Board (MRB) hold area and quarantining product as needed.
• Perform Setup Verifications (SUV) where necessary and trained.
• Perform final inspections and create the Certificate of Conformance for the device shipment.
• Responsible for properly maintaining laboratory equipment and environment in Quality Lab.
• May be assigned additional tasks in support of EAM administration, calibration scheduling, and outside services/testing coordination.
• Other duties as assigned.

• High School Graduate or equivalent (GED)
• One year certificate from College or Technical School involving metrology preferred
• 2-5 years of related experience, preferably with metrology
• Highly organized, detail oriented and works effectively as both a team member and independent contributor.
• Demonstrated proficiency in MS Suite, particularly in Microsoft Word and Excel.
• Ability to work independently with minimal instruction.
• Acts with sound and proactive judgement, seeking clarification as appropriate to minimize/eliminate delays.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals.
• Ability to write routine reports and correspondence.
• Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form.
• Ability to deal with problems involving several concrete variables in standardized situations.
• Knowledge of metrology and measuring tools and equipment
• Programming of OGP and CMM experience required.