QA Technician

Job Description:

Job Title: QA Technician
Location: Acton Massachusetts 01720

Position Overview:
The Quality Technician is a hands-on role supporting the inspection documentation and quality assurance of medical devices during early-stage R&D builds. This position plays a critical role in ensuring product integrity and compliance by performing detailed inspections maintaining accurate records and collaborating with cross-functional teams to uphold quality standards throughout the development process.
The ideal candidate is detail-oriented methodical and committed to maintaining high standards in a fast-paced collaborative environment. Experience in regulated industries especially medical devices is highly valued.

Responsibilities:
Conduct in-process and final inspections of small intricate components and assemblies validation of manufacturing equipment / processes and setup of 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 and perform root cause analysis and investigation activities
Assist in the documenting non-conformances and contributing to root cause analysis and corrective actions
Ensure adherence to cleanroom protocols and quality control procedures during all build activities

Key Decision Rights:
Escalate quality concerns deviations and non-conformances
Provide input on inspection criteria documentation practices and process improvements
Required Skills and Competencies:
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 a 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