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Abbott Senior Quality Technician 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.

SENIOR QUALITY TECHNICIAN

A position of Quality Technician is open in the Structure Heart Division of Abbott, reporting to the Manager of Quality.

CORE JOB RESPONSIBILITIES

  • Conduct functional testing as required by component drawings, manufacturing instructions, and/or test instructions

  • 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 inspection requirements of 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.

  • Records 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

  • Work may require 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;

  • Foster the production team about quality control concerns to improve quality of the product.

  • Maintain quality 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.

  • Supports trending process and maintains Quality Records.

  • Provide Quality support to key processes and product development/improvement projects.

  • Adhere to Good Manufacturing Practices and Good Documentation Practices.

  • Possess a basic understanding of the Quality System; including the Subsystems and is familiar with the Quality System Key processes.

  • Suggests to manager and implements process improvements within own work that fosters a culture of continuous improvement.

  • Support other functional area as needed.

  • Keep abreast of the standards that regulate our industry.

  • Take appropriate action per procedural requirements and schedule when identify any potential nonconformance.

  • Work with engineers and manufacturing to transfer technical information into easy to understand written form, as well as take a hands-on approach to learning and documenting the processes.

  • Ensure storage of samples and documents in the appropriate filling systems.

  • 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 corpjat@abbott.com

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