Medical Equipment Manufacturing Company is seeking a Quality assurnce specialist to work in their Tempe, AZ warehouse.

Schedule is Monday-Friday 7am to 4pm.

Job Overview:

This role performs visual inspections, dimentional, and functional insepcitions of incoming materials.

Responsible for routine returned goods analysis and disposition. Assist with nonconformance and calibration processes.

perform manufacturing process audits and Good Documentation Practice Reviews of manufacturing records, and functional testing of subassemblies and finished products.

Responsibilities and Duties

• Ensure that incoming materials conform to specifications and that documentation of materials, processes, and secondary operations are correct
• Verify and use proper tools and gages correctly to perform inspections.
• Communicate inspection concerns, including test failures and unexpected data results.
• Follow non-conformance procedures to quarantine and disposition materials as directed
• Collect, organize, and communicate data from various sources used by internal quality, manufacturing, and R&D.
• Collaborate with Quality and Engineering team members to perform first-article inspections (FAI)

Qualifications

• Help Quality team members ensure calibrated tools and equipment are appropriately tracked and maintained.
• Follow documented procedures in receiving, reviewing, and recording results for returned goods and customer complaints
• Work with Engineering to create and maintain Inspection Plans (IPs) for new and existing materials.
• Assist Quality Engineering in addressing non-conformances
• Perform Good Manufacturing Practice Audits of production areas and Good Documentation Practice Audits of production records
• Use test equipment and fixtures to test subassemblies and finished products as required.

Education and Experience

• Minimum two years of experience in a regulated manufacturing environment - medical device industry experience preferred (GMP/QSR and ISO 13485)
• High School Degree required. College-level coursework, with a preferred technical background, plus experience in an FDA-regulated company.
• Familiarity with roles in a practical manufacturing environment, including inspection, quality control, and production control
• Prior experience in hand inspection tools and gages typically used to inspect custom parts

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.