Quality Technician
ProClinical
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
$21 per hour
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