Veterans at Abbott
Abbott Senior quality inspector in St. Paul, Minnesota
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
Sr Quality Inspector
A position of Quality Technician is open in the Structural Heart Division of Abbott, reporting to the Manager of Quality.
CORE JOB RESPONSIBILITIES
Responsible for Receiving inspection activities including but not limited to inspection and gathering all defined requirements and documentation to release parts/components.
Responsible for the inspection of components/materials, information for use (IFUs), packaging, and labeling materials.
Responsible for performing in-process and final components, sub-assembly and product inspection.
Measure component dimensions per requirements or inspection plans.
Understand the capability of measuring tools. Utilize small hand tools, calibrated instruments, measuring equipment, microscopes and test fixtures
Understand engineering drawings and the inspection requirements of the components and parts.
Review material product specifications to understand the requirements of the components and parts.
Document non-conformance report once parts fail specifications or requirements.
Read and understand certification of conformance and certification of analysis.
Responsible for Inventory Control including material transfer activities, maintain inventory and inventory logs.
Record inspection and test data as prescribed by written instructions and procedures.
Support Equipment Controls and calibration/PM activities including coordination with Calibration house, update Equipment log
Conduct functional testing as required by component drawings and/or test instructions.
Collaboration with other Abbott divisions.
Recommend improvements to the production process to ensure quality control
Responsible for completing documentation in a timely manner and in accordance with business standards;
Provide timely updates to the production team about quality control concerns to improve quality of the product.
Maintain inspection documentation in accordance with SOPs, WIs and GMP (CFRs)
Resolve quality-related issues in a timely manner.
Perform audits of manufacturing records during assembly to ensure compliance.
Perform final manufacturing Device History Record (DHR) review at close of manufacturing process and product release
Support engineering with other documentation related tasks as required.
Travel up to 10% of the time as necessary to support organizational goals.
Other tasks and duties as assigned.
QUALIFICATIONS and SKILLS
High school diploma or equivalent qualification.
Excellent knowledge of MS Office and Excel
Good math and technical skills.
Strong understanding of quality control standards and testing techniques.
Must have a minimum of 5 years’ experience working in inspection, or related field
5+ years prior medical device experience preferred
Positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory requirements.
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
Very high level of attention to detail and accuracy
Excellent verbal and written communication skills.
Ability to collaborate effectively.
Must be an effective team player with the ability to train other technicians
Confident and open personality who can communicate effectively, both written and orally with people at all levels.
Ability to work efficiently under tight timelines.
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 email@example.com