Abbott Technician II, Quality (2nd Shift) in San Ramon, California
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
We are seeking an experienced, high caliber Technician II, Quality who will work under general supervision on 2nd shift ( 1:30pm – 10:00pm, Monday – Friday)
The Technician II, Quality is responsible for inspection and for ensuring all product specifications are met to comply with regulatory IDEV standards. Performs routine and First Article mechanical and visual inspections of procured materials, manufactured product, tooling and/or processes per IDEV documentation (drawings, specifications, procedures and workmanship standards
Perform General Receiving inspection against specification and procedural requirements.
Document non- conformances as appropriate
Initiate related documentation changes.
Perform Process Control & Monitoring of critical-to-quality parameters and specifications.
Collect data, summarize, and document test results.
Assist with or perform Gage R&R studies.
Assist in writing, executing and documenting equipment, product, process, and test method verifications, qualifications, and validations.
Employs Good Documentation Practices in all aspects of work.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Performs other related duties and responsibilities, on occasion, as assigned.
Must be Able to lift up to 50 pounds at a time unassisted.
Minimum High School Diploma or GED
2 or more years of work experience as an electro mechanical technician
2 or more years electrical and mechanical testing experience
Experience with MS office suite, Word and Excel
Must be Able to lift up to 50 pounds at a time unassisted
Associates or higher degree, Technical training or additional technical certification
Work experience in an environment that Complies with U.S. Food and Drug Administration (FDA) regulations
Work experience within the Medical Device industry
Previous experience in assisting with validations & qualifications, Gage R&R, calibration, test methods, and NCMR dispositioning.
Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory requirements.
Experience with optical measurement equipment, hand tools, gages, pressure and force gage testing, and fixture design.
Training in blueprint reading and experience with sampling techniques.
Good communication and computer skills, including data analysis and report writing skills.
ASQ CQT certification or equivalent preferred.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org