Location: Santa Rosa, CA Pay Rate: $24-$26/hr DOE Schedule: Monday-Thursday
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.
- 1-5 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.
Preferred Experience
- Medical device or regulated manufacturing.
- DHR review.
- GDP/QMS.
- Cleanroom environment.
- QAD, MES, or similar systems.
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