About the role
About Mendaera, Inc.
Mendaera is developing technology that will enable all healthcare providers to do more for their patients. Our platform combines real-time imaging, robotics, and artificial intelligence to make precise and consistent intervention more accessible. Our aim is to eliminate barriers in the patient journey, accelerate recovery, delight customers, and reduce cost of care.
About the Opportunity
The Incoming & Manufacturing Quality Technician is responsible for ensuring the quality and compliance of incoming materials, manufacturing processes, and production documentation in support of medical device manufacturing. The role performs incoming inspections, in-process quality inspections, documentation review, equipment and calibration support, and nonconformance processing to ensure products meet company, regulatory, and customer requirements.
Salary Range: $95,000 to $115,000 (this is an hourly position)
About You
We are looking for candidates who thrive in fast-paced environments, embrace ambiguity, can support the development of frameworks and work products, are willing to engage in both detailed and broader-level analysis, possess critical and systems-thinking abilities, and are detail-oriented.
Responsibilities Include
- 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.
Required Skills and Experience
- 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.
Physical Demands
- Able to work in a fast-paced production environment.
- Ability to lift and handle objects up to 20 pounds.