Medical Device QA Inspector – GMP/ISO 13485

Dexian; Massachusetts; On-site; USD 55,000 - 75,000; Full time

Job summary

Dexian is seeking a Quality Technician to support inspection, documentation, and QA of medical devices during early-stage R&D builds. You will inspect components, record results, and work with engineering to ensure compliance with quality standards.

Responsibilities include reviewing drawings and specifications, maintaining GMP/ISO 13485 documentation, and assisting with validation and non-conformance investigations. Strong attention to detail and clear communication are essential.

Qualifications

• Minimum 3 years of experience in quality, manufacturing, assembly, or a technician/operator role.
• Ability to read and interpret technical drawings and specifications.
• Experience performing precise inspections.
• Familiarity with quality control principles and documentation practices.
• Basic computer skills for data entry and recordkeeping.
• Strong communication skills and the ability to follow detailed procedures.

Responsibilities

• Perform in-process and final inspections of small components and assemblies.
• Review engineering drawings, specifications, and quality documentation.
• Record inspection results, deviations, and observations accurately.
• Maintain quality documentation in accordance with GMP and ISO 13485 standards.
• Assist with equipment and process validation, as well as the setup of inspection and testing procedures.
• Support quality investigations, root cause analysis, and documentation of non-conformances.
• Collaborate with engineering teams to identify and resolve quality issues.
• Follow cleanroom protocols and established quality control procedures.

Skills

Attention to detail

Reading drawings

Basic computer skills

Communication skills

Documentation practices

Job description

Dexian is seeking a Quality Technician to support inspection, documentation, and QA of medical devices during early-stage R&D builds. You will inspect components, record results, and work with engineering to ensure compliance with quality standards.

Responsibilities include reviewing drawings and specifications, maintaining GMP/ISO 13485 documentation, and assisting with validation and non-conformance investigations. Strong attention to detail and clear communication are essential.