Impactful Quality Inspector: Incoming & Manufacturing

Mendaera, Inc.; San Mateo (CA); On-site; USD 95,000 - 115,000; Full time

Job summary

Mendaera, Inc. in San Mateo, CA, seeks an Incoming & Manufacturing Quality Technician to ensure quality of incoming materials and production documentation in a regulated medical device environment.

You will perform inspections, review documentation, support calibration, and help ensure compliance with FDA QMSR, ISO 13485, GMP, and GDP while collaborating with Manufacturing, Engineering, and Regulatory Affairs.

Qualifications

• Minimum 2+ years of quality inspection experience in a regulated manufacturing environment.
• Working knowledge of common inspection tools.
• Experience working with MS Office and Excel or Google Docs and Sheets.
• Experience in medical device manufacturing preferred.
• Ability to read engineering drawings for inspection/acceptance requirements and use precision measuring equipment.
• Knowledge of ISO 13485, FDA QMSR, GDP, GMP, and AQL sampling.
• Experience with eQMS and ERP systems.
• Process-oriented with the ability to plan and perform work.

Responsibilities

• Perform incoming inspection of purchased materials, components, and assemblies using approved inspection procedures and sampling plans.
• Review supplier documentation, engineering drawings, specifications, and acceptance criteria.
• Conduct visual, dimensional, and functional inspections using calibrated inspection equipment.
• Support manufacturing through in-process and in-line inspections to verify compliance with approved procedures and quality standards.
• Review Device History Records (DHRs), travelers, Manufacturing Process Instructions (MPIs), and related production documentation for accuracy and completeness.
• Identify, document, and segregate nonconforming materials; initiate and support Nonconformance Reports (NCMRs) and Material Review Board (MRB) activities.
• Coordinate equipment calibration, preventive maintenance, and equipment status while maintaining calibration records.
• Support product release activities, rework verification, engineering builds, and continuous improvement initiatives.
• Ensure compliance with FDA QMSR (21 CFR Part 820), ISO 13485, Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP).
• Collaborate with Manufacturing, Engineering, Supply Chain, Supplier Quality, and Regulatory Affairs to resolve quality issues and support production.
• Fulfill any other duties as assigned.

Skills

Quality inspection

Regulated manufacturing

MS Office / Excel

Medical device manufacturing

Reading engineering drawings

ISO 13485 / QMSR / GDP / GMP / AQL

eQMS / ERP

Process planning

Job description

Mendaera, Inc. in San Mateo, CA, seeks an Incoming & Manufacturing Quality Technician to ensure quality of incoming materials and production documentation in a regulated medical device environment.

You will perform inspections, review documentation, support calibration, and help ensure compliance with FDA QMSR, ISO 13485, GMP, and GDP while collaborating with Manufacturing, Engineering, and Regulatory Affairs.