Quality Technician

Ensure the Integrity of Innovative Medical Devices

Join a team dedicated to ensuring product integrity and compliance in the medical device sector. This hands-on role supports the inspection, documentation, and quality assurance of medical devices during early-stage research and development builds. You will play a critical role in upholding quality standards by performing detailed inspections, maintaining accurate records, and collaborating with cross-functional teams throughout the development process.

Primary Responsibilities

• Conduct in-process and final inspections of small, intricate components and assemblies
• Validate manufacturing equipment and processes, and set up QA inspection and test processes
• Review and interpret engineering drawings, specifications, and quality documentation to ensure compliance
• Record inspection results, deviations, and observations with precision and clarity
• Maintain accurate and organized documentation in accordance with GMP and ISO 13485 standards
• Collaborate with engineers to identify and resolve quality issues
• Perform root cause analysis and investigation activities
• Assist in documenting non-conformances and contributing to corrective actions
• Ensure adherence to cleanroom protocols and quality control procedures during all build activities

Skills and Requirements

• Strong attention to detail and ability to perform precise inspections under magnification
• Familiarity with quality control principles and documentation practices in a regulated environment
• Ability to interpret technical drawings, specifications, and inspection criteria
• Ability to follow detailed instructions and maintain focus on repetitive tasks
• Strong communication skills and willingness to ask questions and learn
• Familiarity with basic computer tools for data entry and documentation
• Experience working in a regulated manufacturing or R&D environment preferred

Education and Experience

• High School Diploma or equivalent required
• Minimum 3 years of experience in quality, manufacturing, or assembly tech/operator role
• Experience in medical device or cleanroom environments is a plus

Additional Information

• Role is based in Acton, MA and requires on-site presence 5 days per week
• Cleanroom gowning and adherence to GMP/ISO standards may be required
• Key decision rights include escalating quality concerns, deviations, and non-conformances
• Provide input on inspection criteria, documentation practices, and process improvements