Quality Technician

Proclinical; Acton (MA); In loco; USD 34.000 - 48.000; Tempo pieno

Descrizione del lavoro

Proclinical seeks a Quality Technician in Acton, MA to support inspections, documentation, and QA of medical devices during early development.

This on-site contract role emphasizes GMP/ISO standards, meticulous record-keeping, and cross-functional collaboration to ensure product integrity throughout the process.

Competenze

• High school diploma or equivalent required.
• Minimum 3 years of experience in quality, manufacturing, or assembly tech/operator role.
• Experience in medical devices or cleanroom environments is a plus.
• Ability to follow GMP/ISO processes and document precisely.

Mansioni

• Conduct in-process and final inspections of small components and assemblies.
• Review drawings, specifications, and quality documentation for compliance.
• Record inspection results and deviations with precision.
• Maintain organized GMP/ISO 13485 compliant documentation.
• Collaborate with engineers to identify and resolve quality issues.
• Assist in documenting non-conformances and corrective actions.
• Ensure adherence to cleanroom protocols during build activities.

Conoscenze

Attention to detail

Quality control

Documentation

Technical drawings interpretation

Communication

Data entry basics

Regulated manufacturing/R&D

Formazione

High School Diploma or equivalent

Descrizione del lavoro

Quality Technician - Contract - Acton, MA

Do you have an eye for detail and a passion for quality? Help ensure the integrity of innovative medical devices from development through to delivery.

Proclinical is seeking a Quality Technician to join our client's team in the US.

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.

Primary Responsibilities

The successful 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.

Skills & 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

The Quality Technician's responsibilities will be

• 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