Quality Technician

Proclinical; Zug; On-site; CHF 25,000 - 32,000; Full time

Job summary

Proclinical is seeking a Quality Technician for an on-site Acton, MA position focused on ensuring the integrity of medical devices during early-stage R&D. The role involves hands-on inspections, detailed documentation, and collaboration with cross-functional teams to uphold GMP/ISO quality standards.

The ideal candidate has a high school diploma, 3+ years in quality/manufacturing roles, and experience in regulated environments. Cleanroom gowning and GMP/ISO adherence may be required.

Qualifications

• 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.

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.

Skills

Attention to detail

Inspection under magnification

Quality control principles

Interpret drawings & specs

Follow detailed instructions

Communication

Data entry & documentation

Regulated environment experience

Education

High School Diploma or equivalent

Job description

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