Overview
Inspector Jobs in Salt Lake City, UT at Western Metals Recycling LLC
We are seeking a skilled Quality Engineer with experience in both medical device and pharmaceutical environments. The ideal candidate will support quality assurance activities across the product lifecycle, including design, manufacturing, validation, and post-market support, ensuring compliance with FDA regulations, ISO standards, and GMP/GxP guidelines. This individual will play a key role in supporting cross-functional teams, identifying risks, leading investigations, and driving continuous improvement.
Key Responsibilities:
Support design control, verification/validation, risk management (ISO 14971), and change control processes.
Ensure compliance with 21 CFR Part 820, ISO 13485, 21 CFR Part 210/211, and other applicable regulations.
Assist in CAPA processes, nonconformance (NC) investigations, root cause analysis (RCA), and effectiveness verification.
Participate in validation activities (IQ/OQ/PQ) for equipment, processes, and test methods.
Work with manufacturing, engineering, and supply chain to resolve quality issues and improve product reliability.
Support internal and external audits, including FDA inspections and Notified Body assessments.
Create, revise, and maintain SOPs, work instructions, and quality system documentation.
Monitor and analyze quality metrics; generate reports and recommend actions for improvement.
Lead or support initiatives for continuous improvement, lean, and Six Sigma projects.
Qualifications:
Bachelor s degree in Engineering, Life Sciences, or related technical field.
3+ years of experience in a Quality Engineering role within medical device, pharmaceutical, or combination product environments.
Strong knowledge of GMP, GxP, FDA, ISO 13485, 21 CFR 820/210/211.
Experience with risk management, CAPA, change control, and validation protocols.
Proficient in statistical tools (e.g., Minitab, JMP) and quality tools (e.g., FMEA, 8D, Fishbone).
Working knowledge of Quality Management Systems (QMS) and electronic documentation systems.
Strong problem-solving, communication, and collaboration skills.
Preferred Qualifications:
Six Sigma Green or Black Belt.
Experience with combination products, sterile manufacturing, or biopharmaceuticals.
Familiarity with eQMS platforms (e.g., TrackWise, MasterControl, Veeva).
Experience with regulatory submissions or tech transfer.
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Title: Inspector
Company: Western Metals Recycling LLC
Location: Salt Lake City, UT
