Quality Engineer - Medical Device - Franklin, MA - Franklin

About Our Client

My client specializes in designing and manufacturing high-precision parts for advanced medical devices, playing a key role in cutting-edge health care innovations. With a strong commitment to quality and technology, they offer an exciting environment where expertise meets innovation to create life-changing solutions for the medical industry.

• Develop, implement, and maintain quality control processes to ensure compliance with industry standards and regulatory requirements.
• Conduct root cause analysis and implement corrective and preventive actions (CAPA) to address quality issues.
• Collaborate with engineering, production, and regulatory teams to enhance product quality and manufacturing efficiency.
• Perform risk assessments and support validation activities for new and existing processes.
• Analyze quality data, generate reports, and drive continuous improvement initiatives.
• Support audits, including internal, customer, and regulatory audits, ensuring compliance and readiness.
• Train and mentor staff on quality standards, procedures, and best practices.
• Work with suppliers to ensure material and component quality meets specifications.

MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

• Bachelor's degree in Engineering, Quality, or a related field.
• 2+ years of experience in quality engineering, manufacturing, or a regulated industry preferably medical device.
• Strong knowledge of quality standards such as ISO 13485, FDA regulations, or GMP.
• Experience with root cause analysis, CAPA, and process validation.
• Proficiency in quality tools and methodologies such as FMEA, SPC, and Six Sigma.

• Competitive compensation and benefits
• A team that values expertise, problem-solving, and continuous improvement.
• Opportunities for professional development and advancement.
• Rapidly growing organization with a well established reputation.