MedTech Quality Engineer: Injection Molding & Metrology

Eptam Plastics, Inc.; Lancaster (MA); On-site; USD 80,000 - 103,000; Full time

Benefits offered by this job

Health and Wellness Benefits

401k w/ Company Match

Professional Development/On the Job

Job summary

EPTAM Precision Molding in Lancaster, MA is seeking a Quality Engineer to lead metrology-focused activities in a regulated medical device molding environment. You will design measurement methods, execute validations (IQ/OQ/PQ), and drive continuous improvement with cross-functional teams.

You will analyze data, lead failure investigations, and communicate findings to customers and internal stakeholders while ensuring QMS compliance and process capability.

Qualifications

• 3+ years in medical device manufacturing, preferably injection molding
• Strong knowledge of measurement systems and metrology
• Experience designing/ executing IQ/OQ/PQ validation protocols
• Ability to present technical results to customers and internal stakeholders
• Experience in CAPA, root cause analysis and failure investigations (5 Whys, Fishbone, FMEA)
• Familiar with ISO 13485 and 21 CFR 820 compliance

Responsibilities

• Lead metrology activities and design measurement methods for NPI to manufacturing
• Analyze process and product data to identify quality issues and drive improvements
• Perform CMM operation and programming; use advanced gages
• Develop validation activities and write IQ/OQ/PQ validation reports
• Support QMS documentation and regulatory compliance
• Investigate quality issues (CAPA/Complaints/NCMRs) and drive corrective actions

Skills

Measurement systems

Metrology

Capability studies

CMM programming

Validation protocols IQ/OQ/PQ

External customer communication

Root cause analysis

Failure investigations

ISO 13485 & 21 CFR 820

Education

Bachelor’s degree in a relevant technical field

Tools

CMM

eQMS

Job description

EPTAM Precision Molding in Lancaster, MA is seeking a Quality Engineer to lead metrology-focused activities in a regulated medical device molding environment. You will design measurement methods, execute validations (IQ/OQ/PQ), and drive continuous improvement with cross-functional teams.

You will analyze data, lead failure investigations, and communicate findings to customers and internal stakeholders while ensuring QMS compliance and process capability.