Provides independent evaluation of materials, components, and products, and work process within the quality system Quality and production support resource to ensure compliance with policies and procedures within an atmosphere of error prevention and continual improvement.
Main Responsibilities
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Review material, equipment, and systems quality through examination, inspection, measurement, or testing of raw materials, components, sub assembly, final assembly, packaging, labeling and documentation.
Contributes to validation testing as defined on validation protocols with engineering guidance. Ensures that all evidence documentation complies with governing procedures.
Executes product acceptance testing, sampling, inspection, classification or disposal based on engineering dispositions.
Perform measurement for small parts with CNC or Vision System such as Smart scope and Pull Testing
Ensures that all evidence documentation complies with governing procedures.
Audits and verifies processes such as line verification or environmental conformity to prevent quality system and manufacturing impact.
Reviews and verifies compliance of documentation such as batch records, reports of nonconforming materials, inspection records.
May be required to scan, archive, and coordinate record retrieval.
Notifies supervision of issues or errors, providing immediate response.
Executes Testing of samples as part of its daily activities with minor guidance from Quality Supervisor or Quality Engineer.
Identifies and segregates nonconforming material from the production line according to governing documents. Coordinates with the Quality Engineer to prepare and handle the material in and out of the designated quarantine area.
Inputs data to required systems. CATS Web use is limited to run queries and/or input lots, test data.
Assists to set up, train and certified new or transferred Quality Technicians.
Provides ideas for improvement in areas such as quality, productivity, and safety.
Contributes to generate work schedules when required by Quality Supervisor.
Skills
Detail oriented
GMP Background
Vision System experience. Abbott uses Smart scope, but other brand experience is okay.
Can record data.
Worked with Quality system regulations.
Education
Will consider high school with at least 5+ years’ experience, associate’s degree with 3-4 years’ experience, and bachelor’s degree with 1-2 years’ experience. Manager will consider higher educated candidates if they are willing to do the position at pay rate.
Interview: Will interview in-person. Team may test candidates on vision systems experience during interview.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Quality Assurance
Industries
Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing
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