Andrena Chamberlain Email & Phone Number

Utah, United States

Salt Lake City, Utah, United States

Slc, Utah

Greater Salt Lake City Area

Greater Salt Lake City Area

Lead internal auditor, CAPA Coordinator, and currently involved with writing and developing procedures and work instructions (to capture the ISO 13485:2016 updates). Heavily involved with risk management (ISO 14971), root cause analysis, cGMP for Medical Devices (21 CFR Part 820), new product introduction, incoming inspection and outgoing inspection, etc.

Greater Salt Lake City Area

Write and develop procedures and work instructions, conduct internal audits, perform root cause analysis, calibration and maintenance administrator, cGMP for Medical Devices (21 CFR Part 820), ISO 13485, Management Review participant, Risk Management ISO 14971, incoming inspection, etc.

Greater Salt Lake City Area

Develop quality plans, participate in new product developement and risk management, write and review procedures, participate in FDA and ISO audits, conduct quality system audits, work with suppliers in regards to corrective actions (SCAR's), etc.

Involved in MRB, CAPA, ECO review and approval, internal audits, Device History Record creation and review, trend analysis, SOP and Work Instruction creation, root cause analysis, incoming inspection, Lean Manufacturing, etc.