Quality Systems Engineer - Injection Molding & QMS Lead

EPTAM Precision; Lancaster (MA); On-site; USD 85,000 - 95,000; Full time

Job summary

EPTAM Precision Molding in Lancaster, MA is seeking a Quality Systems Engineer to lead and maintain the Quality Management System (QMS) within FDA and ISO 13485 environments. You will drive audits, CAPA, training, and data-driven improvement.

The role requires a Bachelor’s degree in engineering or STEM and at least 3 years of progressive manufacturing/quality experience. Strong analytical skills and collaboration with the Quality Manager are essential.

Qualifications

• Bachelor's degree in engineering or STEM preferred, but not required.
• 3 years of progressive experience in manufacturing and/or quality in FDA and ISO 13485 environments.

Responsibilities

• Perform root cause analysis and resolve problems.
• Manage CAPA and Customer Complaint Systems.
• Perform data analysis and trend reporting for management reviews.
• Oversee implementation and maintenance of the Quality Management System (QMS) and related accreditations.
• Organize internal plant audits and corrective action reporting.
• Assist with external Quality System audits and train internal auditors.

Skills

Root cause analysis

CAPA management

Quality management systems (QMS)

Auditing

Data analysis

Process improvement

Training and documentation

Education

Bachelor's degree in engineering or STEM

Job description

EPTAM Precision Molding in Lancaster, MA is seeking a Quality Systems Engineer to lead and maintain the Quality Management System (QMS) within FDA and ISO 13485 environments. You will drive audits, CAPA, training, and data-driven improvement.

The role requires a Bachelor’s degree in engineering or STEM and at least 3 years of progressive manufacturing/quality experience. Strong analytical skills and collaboration with the Quality Manager are essential.