QA Technician

Signature Consultants; Massachusetts; On-site; USD 65,000 - 90,000; Full time

Job summary

Signature Consultants is seeking a Quality Technician to support inspection, documentation, and QA for early-stage medical device R&D builds in Acton, MA. The role requires meticulous inspection, accurate record-keeping, and collaboration with engineers to uphold GMP and ISO 13485 standards.

The ideal candidate has at least 3 years in a regulated manufacturing or R&D environment, familiar with cleanrooms and documentation practices.

Qualifications

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

Responsibilities

• Perform in-process and final inspections of small components and assemblies; validate manufacturing equipment/processes; 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 root cause analysis and corrective actions.
• Ensure adherence to cleanroom protocols and quality control procedures during all build activities.

Skills

Attention to detail

Inspect under magnification

Reading drawings

Quality documentation

Regulated environment

Communication

Data entry

Root cause analysis

Education

High School Diploma or equivalent

Job description

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

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.