Quality Technician

Work Location: Norfolk County, MA

Summary:

Seeking a Quality Technician to support operations by developing and executing chamber mapping plans, maintaining chamber systems, and supporting complaint investigations. This role requires hands-on testing, data analysis, and collaboration with engineering and quality teams to ensure compliance with quality standards and continual improvement of processes.

Responsibilities:

• Design and implement chamber mapping plans, including IQ/OQ/PQ protocols, and coordinate with engineering and site personnel for execution and data collection.
• Analyze data logger results, review findings with engineering, and prepare comprehensive reports for documentation and approval.
• Support investigations into customer complaints by verifying component specifications, conducting validation testing, and developing corrective actions.
• Review and update quality standards and policies to ensure ongoing compliance with regulatory and industry requirements.
• Lead and facilitate problem-solving teams using tools such as 5-Why’s, Fishbone Diagrams, and FMEA to address quality issues.
• Participate in new product development teams, representing quality assurance and ensuring quality requirements are met throughout the process.
• Drive continual improvement initiatives, including 5S, risk assessments, process mapping, and lean methodologies to enhance the quality system.
• Ensure all activities comply with ISO 9001:2015 and other relevant standards, and actively support health, safety, and environmental regulations.

Qualifications:

• BS degree in engineering or technical field with at least 3 years of experience in a manufacturing environment.
• Experience with chamber/temperature mapping, validation testing, and data logger analysis (IQ/OQ/PQ work).
• Knowledge of Quality Management System standards (ISO 9001:2015, AS9100, IATF 16949) and cGMP environments.
• Strong quality and investigation skills, including complaint investigations, CAPA, and working within a QMS/ISO or cGMP environment.
• Ability to analyze data, present findings, and collaborate with engineering teams; skilled in hands-on testing in a manufacturing setting.
• Proficient in Microsoft Word, Excel, Access; experience with manufacturing ERP software applications.
• Excellent verbal and written communication skills; fluent in English.
• Ability to multitask, adapt to changing priorities, and work with associates at all organizational levels.
• Ability to be physically active (lifting, standing, bending, reaching) and lift up to 23 KG occasionally.
• Travel up to 25% domestically and internationally.
• Preferred: Bachelor’s degree with at least 3 years in quality assurance, Quality System auditing experience, Six Sigma Green Belt, experience with Quality Management System Software, direct customer and supplier interaction, and advanced Microsoft Office skills.
• Behavioral: Ability to work in a fast-paced environment, focus on results, collaborate effectively, maintain a positive attitude, and communicate progress and obstacles.

Published Category: Quality & Validation