Quality Engineer - Medical Device Molding & Metrology

Automatic Data Processing, Inc.; Lancaster (MA); On-site; USD 80,000 - 103,000; Full time

Benefits offered by this job

Professional Development

Health benefits

Safe work environment

Recognition program

Tuition reimbursement

401k with company match

EAP

Job summary

EPTAM Precision Molding in Lancaster, MA is seeking a Quality Engineer to support plastic injection molding operations in a regulated medical device manufacturing environment. The role emphasizes metrology, measurement systems, and validation (IQ/OQ/PQ), with responsibility for leading failure investigations, CAPA, and quality improvements across cross-functional teams.

You will design and execute validation protocols, manage calibration, and maintain QMS documentation to ISO 13485 and 21 CFR

Qualifications

• 3+ years of experience in medical device manufacturing, preferably in injection molding.
• Experience with measurement systems, metrology, and capability studies, including CMM programming.
• Proven experience designing and executing IQ/OQ/PQ validation protocols.
• Demonstrated ability to present technical findings to external customers and internal stakeholders.
• Strong problem-solving skills with experience in root cause analysis and failure investigations.
• Comfortable working in regulated environments (ISO 13485, 21 CFR 820).

Responsibilities

• Execute metrology and measurement practices in NPI to manufacturing and quality control; create quality plans.
• Analyze process and product data; identify quality issues and drive systemic improvements.
• Evaluate production processes to meet customer requirements.
• Use SPC to analyze data and assess process stability and capability.
• Drive process improvements to reduce variation and enhance quality.
• Collaborate with Operations to design, execute, and document validation activities; write IQ/OQ/PQ reports.
• Monitor and maintain QMS documentation and reporting of quality issues.
• Investigate CAPA, complaints, NCs; ensure compliance with FDA and ISO requirements.
• Support with inspection planning and data collection; assist with CAPA/Change Control.
• Measure components using CMM/vision systems and handheld gauging.

Skills

Medical device manufacturing

Measurement systems

Metrology

Capability studies

CMM programming

Validation protocols

Root cause analysis

Failure investigations

CAPA

Regulated environments

Education

Bachelor’s degree in STEM or related field

Job description

EPTAM Precision Molding in Lancaster, MA is seeking a Quality Engineer to support plastic injection molding operations in a regulated medical device manufacturing environment. The role emphasizes metrology, measurement systems, and validation (IQ/OQ/PQ), with responsibility for leading failure investigations, CAPA, and quality improvements across cross-functional teams.

You will design and execute validation protocols, manage calibration, and maintain QMS documentation to ISO 13485 and 21 CFR