Quality Systems Engineer, Injection Molding & CAPA Lead

Socket.dev; Lancaster (MA); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Health and wellness benefits

401k with company match

Tuition reimbursement

Employee assistance program (EAP)

Professional development/on the job

Recognition and rewards program

Merit increases

Job summary

EPTAM Precision Molding in Lancaster, MA is seeking a Quality Systems Engineer to oversee the QMS, lead audits, and champion quality improvements. You will train teams, manage CAPA and customer complaint processes, and drive data-driven improvements across the organization.

The role requires a background in manufacturing QA/ compliance, with experience in FDA and ISO 13485 environments, and a dedication to maintaining product integrity and process excellence.

Qualifications

• Bachelor’s degree in an engineering field or related technical area (STEM) preferred, but not required.
• 3 years of progressive experience in manufacturing and/or quality within FDA and ISO 13485 environments.

Responsibilities

• Oversee effective implementation of the Quality Management System (QMS).
• Lead audits across all areas of the business.
• Provide training and champion the QMS.
• Manage CAPA and customer complaints systems and reporting.
• Perform root cause analysis and resolve problems.
• Maintain and improve internal audit processes and corrective actions.
• Coordinate review of quality procedures for continuous improvement.

Education

Bachelor’s degree in engineering or related STEM field

Job description

EPTAM Precision Molding in Lancaster, MA is seeking a Quality Systems Engineer to oversee the QMS, lead audits, and champion quality improvements. You will train teams, manage CAPA and customer complaint processes, and drive data-driven improvements across the organization.

The role requires a background in manufacturing QA/ compliance, with experience in FDA and ISO 13485 environments, and a dedication to maintaining product integrity and process excellence.