Quality Systems Engineer - Manufacturing Compliance & CAPA

100Hires, Inc.; Raynham (MA); On-site; USD 85,000 - 115,000; Full time

Job summary

100Hires, Inc. is seeking a Quality Engineer to drive Device History Records, process validations, and CAPA investigations in a manufacturing setting in Massachusetts.

You will mentor technicians, collaborate with Design and Manufacturing Engineers, and ensure compliance with ISO, QSR, UL and other standards while leading deviation/waiver guidance and continuous improvement initiatives.

Qualifications

• Bachelor’s degree in engineering or a related field.
• 2–5 years of Quality Engineering experience, preferably in manufacturing.
• Proficiency with quality engineering tools and techniques.
• Strong knowledge of ISO/QSR/UL/MDD/TGA regulations and standards.
• Proficient with Microsoft Office and Minitab.
• Excellent communication and collaboration skills.

Responsibilities

• Audit history records and ensure compliance with quality systems.
• Lead test method validation protocols and reports.
• Oversee manufacturing quality and provide deviation/waiver guidance.
• Lead customer complaint investigations and CAPA analyses.
• Collaborate with Design and Manufacturing Engineers on processes; coordinate validations and capability studies.
• Mentor 1–3 technicians/inspectors.

Skills

Quality engineering tools

Regulatory knowledge

Minitab

Microsoft Office

Communication

Education

Bachelor’s degree in engineering or related field

Tools

Minitab

Microsoft Office

Job description

100Hires, Inc. is seeking a Quality Engineer to drive Device History Records, process validations, and CAPA investigations in a manufacturing setting in Massachusetts.

You will mentor technicians, collaborate with Design and Manufacturing Engineers, and ensure compliance with ISO, QSR, UL and other standards while leading deviation/waiver guidance and continuous improvement initiatives.