Quality Engineer

Job description

Quality Engineer
Devens, MA
1st Shift: 8:30 AM – 4:30 PM
$40.00/HR
12-Month W2 Contract

Quality Engineer Overview:
We are looking for a meticulous Quality Engineer to enhance our quality assurance efforts throughout our operations. In this role, you will leverage your skills in root cause analysis, quality engineering fundamentals, and adherence to regulatory standards to refine processes, address issues, and uphold product and process integrity. This position provides practical experience in assembly and cleanroom settings, offers collaboration opportunities with diverse teams, and provides insights into ERP systems.

Quality Engineer Key Responsibilities:

• Perform root cause analysis and spearhead investigations to determine corrective and preventative measures.
• Assist with customer, regulatory, and internal audits.
• Oversee validations, calibration programs, and environmental monitoring initiatives.
• Execute internal and supplier audits to verify compliance with ISO 9001 and FDA standards.
• Gather and evaluate data for metrics, trend analyses, quality system assessments, and complaint resolutions.
• Work collaboratively with various teams and handle external customer complaints effectively.
• Revise and maintain SOPs, Quality Management System documentation, and the approved supplier list.
• Utilize ERP systems to monitor and report on quality metrics and support ongoing improvement initiatives.

Quality Engineer Qualifications:

• Education: A Bachelor’s degree in Engineering or a related discipline.
• Experience: At least 3 years in a Quality Engineer role or a comparable position.
• Proficient in root cause analysis and conducting quality investigations.
• Practical experience in assembly or cleanroom environments is preferred.
• Familiarity with ISO 9001 and other relevant regulatory standards.
• Experience with ERP systems is advantageous.
• Quality Engineering certification (CQE/CQA) or Lean Six Sigma certification is preferred.
• Demonstrated ability to work with cross-functional teams and address external customer complaints efficiently.
• Exceptional written and verbal communication skills, strong organizational capabilities, and keen attention to detail.
• Proficient in Microsoft Office Suite (Word, Excel, Access).