Summary: Responsible for inspecting/testing electronic and mechanical devices, assemblies, components, and parts to ensure conformance to specifications.
Essential Duties and Responsibilities:
* Perform First Article Inspections (FAI), generate and review FAI reports.
* Inspect incoming products; approve for use in production.
* Conduct source inspections and/or product audits at supplier facilities.
* Inspect products in manufacturing areas as needed.
Final Inspection/Testing:
* Audit finished goods and release acceptable products to shipping.
* Non-conforming Material Processing:
* Identify root causes of non-conforming products.
* Maintain quarantine for non-conforming/rework materials and ensure proper segregation of products.
* Enter complaint data, evaluate, and coordinate investigations.
* Complete the Reportable Event Determination Checklist when necessary.
* Process material receiving and non-conforming reports.
* Ensure QA documents meet established Quality System standards.
Other Responsibilities:
* Support statistical process control and other initiatives.
* Alert supervisor of failures/non-conformances.
* Review existing solutions and develop proactive problem-solving methods.
* Provide guidance and training to non-exempt staff.
Additional Tasks:
* Evaluate returned products and assist with failure investigations.
* Develop product quality specifications and assist in supplier/manufacturing problem-solving.
* Maintain knowledge of inspection practices, products, and related regulatory requirements (CHAP, HIPAA, and QSR).
Education/Experience:
* 3-5 year's directly related experience specifically working within cGMP and/or ISO9001 compliant organizations, or
* Associate's degree and 3 year's directly related experience specifically working within cGMP and/or ISO9001 compliant organizations, or
* Bachelor's degree in Science and 1-2 year's directly related experience specifically working within cGMP and/or ISO9001 compliant organizations.
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 California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.