Review lot history records and Device History Records (DHR) for completeness, accuracy, SOP compliance, and Good Documentation Practices (GDP). Perform inspections, audits, configuration checks, functional testing, and product testing.
Numbers & Facts
Location
Santa Rosa, CA
Description
Location: Santa Rosa, CA Pay Rate: $24$26/hr DOE Schedule: MondayThursday
Position Summary
Perform inspections of components, subassemblies, and finished medical devices to ensure compliance with quality standards, procedures, and regulatory requirements. Key Responsibilities
Perform inspections, audits, configuration checks, functional testing, and product testing.
Inspect components, subassemblies, finished products, purchased components, and tools.
Review lot history records and Device History Records (DHR) for completeness, accuracy, SOP compliance, and Good Documentation Practices (GDP).
Use mechanical and/or electrical measurement instruments.
Accurately document inspection and testing results.
Perform product rework as needed.
Identify quality issues and report discrepancies or recommendations for corrective action.
Work in a cleanroom environment and follow required protocols.
Perform temperature and particle-count monitoring.
Process transactions in QAD ERP and MES systems.
Manage multiple priorities in a fast-paced manufacturing environment.
Requirements
High School Diploma or equivalent required.
15 years of Quality Control experience.
Medical device industry experience preferred.
Ability to follow technical procedures, work instructions, SOPs, and specifications.
Ability to read technical drawings and identify discrepancies.
Mechanical aptitude and working knowledge of measurement instruments.
Familiarity with quality standards and regulated manufacturing.
Strong documentation, communication, math, and problem-solving skills.
Reliable, accountable, and able to work effectively across teams.