Abbott is looking to ensure quality assurance responsibilities are met in routine tasks to apply and maintain quality requirements for processing components and other materials into finished goods and products.
Requirements
- Must be knowledgeable in using measurement equipment and tools such as 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.
- Must be familiar with current software such as Microsoft Excel, Word, Access, which are used in generating reports and statistics.
Responsibilities
- 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.
- Ensures that product, at all stages of inspection, and 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 non-conformance report.
Other
- Requires an AA degree or technical education with a minimum of one year related experience or equivalent combination of education and experience.
- Good verbal and written communication skills.
- Must be able to lift weight up to 50 lbs.
- Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Lift, carry, push or pull weights of more than 20 pounds/9 kilos on a regular/daily basis
