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Calibration Technician I QC
Location: US-CA-Carlsbad
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This position is responsible for supporting the Calibration System to ensure that inspection tools, test equipment, and custom gauging are properly calibrated and documented. This role must communicate well with Calibration team to ensure compliance with Alphatec Spines Calibration procedures, the ISO 13485 Standard and the CFR Title 21 part 820 Regulations. Essential Duties and Responsibilities Accurately prepare and maintain calibration records on all tools and inspection equipment requiring calibration Perform calibration, traceable to NIST, on tools such as calipers, micrometers, height gauges, hard gauges and indicators Perform Calibrations on custom gauging utilizing CMM and Vision system; including programming and verification of recipes used for measurements Work with outside calibration contractors on calibration requirements, calibration reports, gauge drawings, etc. as required to ensure all required outside calibration is completed accurately and is properly documented Perform Product lot inspections using CMM or Vision system to support QC inspection as needed Maintain and control the Calibration System to ensure compliance to Alphtecs procedures, ISO 13485 and CFR title 21 Part 820 regulations Serve as a point of contact for coordination and resolution of out-of-tolerance and out-of- repair conditions Analyze data using Smart Profile as needed to support calibration or first article tasks Maintain calibration information in the calibration database Issue monthly calibration schedules identifying tools and equipment that are due for calibration Help develop and support ways to manage cost and improve the calibration system. Perform Mechanical Inspections Read, understand, and interpret engineering (blue print) drawings and associated GD&T (Geometirc Dimension & Tolerancing) Perform complex mechanical, visual and functional inspection as needed Other duties assigned as neededRequirements The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. - Good communication skills, both verbal and written
- Strong organization skills and attention to detail
- Basic math and computer skills required
- Advanced understanding of calibration principles
- Advanced experience using equipment such as vision systems, super micrometers, height gauges, comparator and pin gauges
- CMM and Vision system programming and inspections knowledge/experience
- Working knowledge of 21 CFR (Code of Federal Regulations), Part 820 and ISO 13485
Education and Experience
- High School Diploma or equivalent
- 3+ years experience with direct hands on mechanical inspection of precision machined parts; experience working in a Quality Assurance/ Quality Control capacity; medical device industry experience strongly desired.
- Preferred to have demonstrated capabilities and understanding of metrology and GD&T
For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable). ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.
Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidates qualifications, education, skill set, years of experience, and internal equity. $26.00 to $35.00 Full-Time Hourly Range
Alphatec Spine
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