Quality Engineer — Med Device & Process Improvement

Mount Kemble Search Group; Sturbridge (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

Mount Kemble Search Group is seeking a Quality Engineer to support quality initiatives across manufacturing operations in a regulated environment. The role ensures products, processes, and systems meet quality standards while driving continuous improvement.

The ideal candidate has experience with quality engineering, root cause investigations, SPC/DOE, and GMP/QMS, and is comfortable working with ERP and QA documentation on site in Fiskdale, MA.

Qualifications

• Bachelor's degree in Engineering, Quality, Manufacturing, or related field, or equivalent experience.
• Minimum 1 year of experience in Quality Engineering, Quality Assurance, or a related manufacturing environment.
• Strong understanding of quality systems and manufacturing processes.
• Proficiency with Microsoft Office applications.
• Excellent analytical, organizational, and problem-solving skills.
• Strong written and verbal communication abilities.

Responsibilities

• Partner with production to monitor product quality and address deviations.
• Support quality objectives aligned with customer requirements and business goals.
• Lead root cause investigations and corrective actions.
• Analyze quality data to identify trends and opportunities for improvement.
• Support quality planning for new and existing products.
• Collaborate with engineering to ensure quality by design and manufacturability.
• Conduct inspections, audits, validations, and quality reviews.
• Maintain quality documentation in ERP and QMS.
• Ensure compliance with internal procedures and regulatory standards.
• Support customer, supplier, and internal quality initiatives.

Skills

Quality systems

Manufacturing processes

Problem solving

Analytical skills

Communication skills

Microsoft Office

Education

Bachelor's degree in Engineering/Quality/Manufacturing

Tools

Minitab

SolidWorks

Vision inspection systems

ERP systems

Job description

Mount Kemble Search Group is seeking a Quality Engineer to support quality initiatives across manufacturing operations in a regulated environment. The role ensures products, processes, and systems meet quality standards while driving continuous improvement.

The ideal candidate has experience with quality engineering, root cause investigations, SPC/DOE, and GMP/QMS, and is comfortable working with ERP and QA documentation on site in Fiskdale, MA.