Quality Engineer

Job Title: Quality Engineer

Work Location: Norfolk County, Massachusetts

Summary:

Seeking a Quality Engineer to independently manage quality processes, inspections, supplier quality, and audits. This role involves cross-functional collaboration and maintaining quality documentation, with a focus on regulated industry standards.

Responsibilities:

• Oversee and resolve nonconforming product issues, including investigations, root cause analysis, and corrective/preventive actions.
• Conduct incoming and first article inspections to ensure product compliance and quality standards.
• Manage supplier quality through audits, corrective action requests, assessments, and questionnaires.
• Maintain safety data sheet (SDS) databases and provide support to safety initiatives and committees.
• Support both internal and external quality audits, ensuring compliance with relevant standards.
• Develop, update, and maintain Quality Management System (QMS) documentation, including procedures and work instructions.
• Participate in and occasionally lead cross-functional teams addressing innovation, engineering changes, nonconforming products, and customer complaints.
• Provide regular updates to product management on product health using key performance indicators and act as a resource for process and standards inquiries.

Qualifications:

• Bachelor's degree in engineering (mechanical preferred; other disciplines considered).
• 2–5 years of quality engineering experience, preferably in regulated industries such as medical device or aerospace.
• Working knowledge of ISO 9001:2015 standards.
• Understanding of mechanical and electrical assemblies.
• Experience with root cause analysis and preventive action methodologies.
• Ability to interpret ASME Y14 drawings and apply GD&T principles.
• Hands-on experience with inspection equipment, methods, and reporting.
• Process mapping experience.
• Strong written and verbal communication skills, with the ability to manage challenging conversations constructively.
• Ability to work independently with minimal supervision.
• Familiarity with CE marking, REACH, RoHS, EU Directives, and Notified Bodies is a plus.
• Experience with Lean, 6S, Six Sigma, or Kaizen methodologies is desirable.
• Knowledge of JIRA or similar task tracking tools is beneficial.
• Experience with Microsoft Dynamics 365 is advantageous.
• CAD experience (SolidWorks, Creo, or Fusion) is a plus.
• Exposure to software development is considered an asset.
• Ability to perform long stretches of sitting and repetitive tasks.
• Capable of occasionally lifting up to 50 lbs.

Published Category: Quality & Validation