Quality Assurance Specialist (Gardner, Ma)

Overview

Responsible for performing incoming and outgoing inspections as well as maintaining the electronic documentation system / recordkeeping processes. Inspects products, assists engineers, conducts tests, and collects data.

Principal Responsibilities

• Perform dimensional and visual first article and in-process/final inspection on raw material, parts, gages, and other equipment, accepting material/product or referring for quality review based on findings.
• Prepare inspection reports; ensure material traceability.
• Initiate Nonconformances (NCR) and Supplier Corrective Action Reports (SCARs); facilitate Material Review Board (MRB) meetings.
• Use a variety of fixed and variable measuring instruments.
• Monitor and coordinate Engineering Change Order (ECO) activity across the organization ensuring compliance with the Quality Management System (QMS); support QMS maintenance for compliance with FDA QSR, ISO 13485, and other regulatory requirements.
• Ensure compliance with electronic document control workflows.
• Coordinate QA/QC tasks with cross functional teams across the organization: support product development teams; review Device History Records (DHRs) for completeness and accuracy; execute receiving procedures & support shipping activities.
• Support and promote continuous improvement initiatives to meet business objectives.
• Perform miscellaneous duties and projects as assigned and required.

Training, Skills, Knowledge and/or Experience

• Demonstrated ability to manage records, document controls, and change controls.
• Experience using precision measuring equipment.
• Experience interfacing with stockroom, production control, purchasing, and engineering personnel.
• Working proficiency with Microsoft 365 apps, experience using ERP/MRP/PLM systems preferred.
• Experience in FDA QSR and/or ISO 13485 or other regulated industry environments preferred.
• Experience working in a product development environment a plus.
• Experience with QMS internal auditing and Minitab usage a plus.

Education Requirements

High School Diploma or GED required. Bachelor’s degree or equivalent level of education preferred. Minimum of 3 years of QA/QC related experience required.