Medical Device Quality Engineer - Injection Molding

Regulatory Jobs; Lancaster (MA); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Professional Development/On the Job Tr

Health and Wellness Benefits

Clean, Friendly, Safe work Environment

Recognition and Rewards Program

Tuition Reimbursement

Competitive Pay/Merit Increases

401k w/ Company Match

Employee Assistance Program (EAP)

Job summary

EPTAM Precision is seeking a Quality Engineer for our plastic injection molding operations in Lancaster, MA. The role emphasizes metrology, measurement systems, and IQ/OQ/PQ validation to support regulated medical device manufacturing.

You will lead failure investigations, communicate results to customers and stakeholders, and partner with cross‑functional teams to drive continuous improvement across the quality management system.

Qualifications

• 3+ years in medical device manufacturing or injection molding
• Strong knowledge of measurement systems, metrology, and capability studies
• Experience designing and executing IQ/OQ/PQ validation protocols
• Experience presenting technical findings to customers and internal stakeholders
• Strong problem-solving skills with CAPA, root cause analysis and failure investigations
• Comfortable in regulated environments (ISO 13485, 21 CFR 820)

Responsibilities

• Lead metrology and measurement design for NPI to manufacturing and quality control.
• Analyze process and product data to identify quality issues and drive improvements.
• Evaluate production processes to ensure they meet customer specs.
• Use SPC to determine process stability and capability.
• Drive process improvements to reduce variation and improve quality.
• Coordinate validation activities and write IQ/OQ/PQ reports for equipment and processes.
• Maintain QMS documentation and reporting of quality issues and projects.
• Support CAPA, complaints, NCMRs, and change control across the site.

Skills

Medical devices

Measurement systems

Metrology

IQ/OQ/PQ validation

Root cause analysis

CAPA/NCMR

Cross-functional teamwork

Education

Bachelor's in STEM

Job description

EPTAM Precision is seeking a Quality Engineer for our plastic injection molding operations in Lancaster, MA. The role emphasizes metrology, measurement systems, and IQ/OQ/PQ validation to support regulated medical device manufacturing.

You will lead failure investigations, communicate results to customers and stakeholders, and partner with cross‑functional teams to drive continuous improvement across the quality management system.