Neptune Medical
Quality Technician
Burlingame, California, United States
Sponsorship not specified$35k-$40kDetected 62 days ago
GMPFDA RegulatoryMedical DevicesCollaborationMicrosoft Office
About the role
- The technician works closely with Manufacturing, Quality Engineering, and cross-functional teams to ensure rapid response to quality concerns and compliance with applicable quality system regulations (e.g., FDA 21 CFR Part 820, ISO 13485).
- Assist in root cause investigations and corrective and preventive actions (CAPA)
- Data Collection & Continuous Improvement
Responsibilities
- Accurately document inspection and test results in device history records (DHRs) and other quality records
- Maintain traceability of materials and finished goods throughout production
- Identify, document, and segregate nonconforming materials
- Support containment activities, including line clearance, product holds, and sorting/rework activities
- Collaborate with Quality Engineers to analyze trends and recurring issues
- Collect and analyze in-process quality data to support process monitoring and improvement initiatives
- Partner with Manufacturing and Engineering teams to implement process improvements and error-proofing solutions
- Operate, maintain, and calibrate inspection and test equipment (e.g., calipers, microscopes, gauges)
- Support equipment calibration and environmental monitoring programs as needed
- Perform basic product or material testing in accordance with validated methods
Requirements
- Working knowledge of FDA Quality System Regulation (21 CFR Part 820) and/or ISO 13485
- Experience with inspection methods, sampling plans, and interpreting engineering drawings and specifications
- Proficiency in Microsoft Office and electronic quality management systems
Nice to have
- Familiarity with nonconformance systems, CAPA, and root cause analysis tools (e.g., 5 Whys, Fishbone)
- Hands-on experience with dimensional and visual inspection equipment
- Understanding of validation activities (IQ/OQ/PQ)
- Experience supporting audits and regulatory inspections
- Our job titles may span more than one career level.
- The starting hourly rate for this role is between $35-$40/hour depending on experience.
- High school diploma or equivalent required
- Associate degree or technical certification preferred
Compensation
- The actual base pay is dependent upon many factors, such as: education, training, transferable skills, work experience, business needs, and location.
Benefits
- Perform incoming, in-process, and final inspections of components, subassemblies, and medical devices in accordance with approved procedures, drawings, and sampling plans
Company info
- a fully flexible medical robot that enables doctors to reach deep into human anatomy.
- Triton Robotic Endoscopy will disrupt flexible endoscopy and set a new standard in outcomes for decades to come.
- Quality Technician
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