QA Technician

Lancesoft; Acton (MA); On-site; USD 55,000 - 85,000; Full time

Job summary

Lancesoft in Acton, MA is seeking a QA Technician to support inspection, documentation, and quality assurance of medical device concepts during early R&D builds. The role demands precise inspections, rigorous record-keeping, and collaboration with cross-functional teams to uphold quality standards and regulatory compliance.

The successful candidate will have at least 3 years in a quality or manufacturing setting, preference for medical device or cleanroom experience, and will work on-site five

Qualifications

• High school diploma or equivalent required.
• Minimum 3 years in a quality, manufacturing, or assembly tech/operator role.
• Experience in medical device or cleanroom environments is a plus.

Responsibilities

• Perform in-process and final inspections of components and assemblies.
• Review specifications and drawings to ensure compliance; record results clearly.
• Maintain GMP/ISO 13485 compliant documentation and records.
• Collaborate with engineers to identify quality issues and contribute to corrective actions.
• Assist in documenting non-conformances and root-cause analysis.
• Follow cleanroom protocols and QC procedures during build activities.

Skills

Attention to detail

Precision inspection

Documentation & record-keeping

Reading engineering drawings

Quality control principles

Education

High School Diploma or equivalent

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.