Abbott Senior Quality Technician in Roseville, Minnesota
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.
This position is responsible for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within new product development, manufacturing, or system/services support.
Impact this role will have:
Perform inspection of production operations, including documenting inspection and audit results.
Perform final product inspections against specification and procedural requirements.
Document nonconformances as appropriate and assist in the resolution of nonconformances.
Monitor and/or perform calibration and maintenance of all test equipment and fixtures.
Initiate related documentation changes.
Perform Process Control & Monitoring of critical-to-quality parameters and specifications.
Collect data, summarize, analyze, perform basic statistical analysis on, and document test results
Assist with or perform Gage R&R studies.
Assist with the selection, installation and programming of precision measuring equipment.
Assist in designing, building, and evaluation of test methods and inspection fixturing, providing improvement recommendations.
Create and maintain control plans for products and processes.
Assist in writing, executing and documenting equipment, product, process, and test method verifications, qualifications, and validations.
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.
High School degree required; 2 year technical degree preferred.
5+ years experience.
Ability to work 2nd shift, 10:00 AM - 6:30 PM.
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.
Prior medical device experience preferred.
ASQ CQT certification or equivalent preferred.
Experience working in a broader enterprise/cross-division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Ability to maintain regular and predictable attendance.
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