IQA Technician I
Irving, TX 75038 US
- Supports manufacturing and testing operations adhering to Good Manufacturing Practices and Good Laboratory Practices to satisfy regulatory requirement for receiving and inspection.
- Performs all job duties in full accordance with the Global and Technical standards and complies with Quality System (QS) requirements. Ensures parts are compliant for all parts going to the manufacturing floor and any parts going directly to the customer.
- Completes tier 1 inspections per the inspection plan and associated drawings in support of build schedules. Tier 1 inspections includes manual routine inspections utilizing hand tools such as calipers, gauges (ring, pin, thread, height), rulers as well as visual inspections to test inbound material that will be used to assemble complex medical devices. May operate upper level instrumentation.
- Performs visual and dimensional inspections through application of cable harness assembly and printed circuit board assembly.
- Maintains accurate inspection records, filing systems and appropriate documentation to conform to all quality and GMP regulations.
- Accepts and rejects supplier lots based on inspection results.
- Documents the non-conformance or suspected non-conformance to standards (i.e. manufacturing documentation, material/ component specifications, operating procedures, and domestic/ international standards) through the identification of unsuccessful audits, the completion of required paperwork, system transactions, and affixing his or her mark (i.e. stamp, sign-off or signature).
- Initiates discrepant material reports.
- Assists in gathering, analyzing and trending of data.
- Recommends changes to policies and procedures.
- Takes initiative to ensure work is done accurately and completely. Performs assignments of moderate complexity. Applies existing work methods to different known situations. Problems involve recurring, routine situations; usually refers more complex problems to supervisor or more senior level personnel within the Quality organization.
- Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, ISO or other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Adheres to all environmental, health and safety SOPs, equipment, policies and procedures, including any department specific requirements.
- High School Diploma or GED required
- 0-2 years of work experience performing incoming dimensional inspections. In lieu of experience, Bachelors degree or technical diploma preferred, but not required."