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.
Performs or assists in performing quality assurance responsibilities in routine tasks to apply, and maintain quality requirements for processing components and other materials into finished goods and products. This is an entry-level position and normally receives general instructions on routine assignments and detailed instructions for new activities. Under close supervision, works with quality assurance and manufacturing personnel to ensure effective inspection and testing procedures are implemented and maintained.
- Reviews device history records, manufacturing records and Quality Assurance records to verify that the information is accurate and complete and that all the specifications have been met.
- Closely follows all procedures, specifications (and accurate in performing tasks. Must employ good documentation practices in all aspects of the job.
- Ensures that product, at all stages of inspection, maintains proper identification, traceability, and inspection and test status.
- Performs general receiving inspection, in-process, and final inspection of product, packaging and labeling.
- Conducts visual, dimensional and functional inspection, as directed by quality assurance procedures and other specifications.
- Performs physical testing such as packaging peel tests; polymer product break load and ultimate elongation.
- Ensures measurement, test and inspection equipment is calibrated and in good condition.
- Generates nonconformance report.
- Fills out, organizes, reviews, maintains and archives quality control records.
- Employs statistical sampling techniques in routine inspection and testing activities.
- Performs other duties as required by the Quality Assurance Operations management.
- Requires an AA degree or technical education with a minimum of one-year related experience or equivalent combination of education and experience.
- Must be knowledgeable in using measurement equipment and tools such as microscopes, calipers, gages, micrometers, etc.
- Experience in or familiarity with regulatory requirements such as FDA GMP, ISO and Quality Systems Regulations.
- Must be able to read blueprints and schematics.
- Understanding of basic inspection techniques.
- Proficiency in using basic math skills to obtain test and inspection results.
- Previous experience in the medical device industry preferred.
- Good verbal and written communication skills.
- Must be familiar with current software such as Microsoft Excel, Word, Access, which are used in generating reports and statistics.
- Must be able to lift weight up to 50 lbs.
- This individual must be able to withstand long periods of time inside Clean Room environment.
The above Job Description is intended to communicate the general function of the mentioned position and by no means shall be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.