Quality Engineer - Medical Devices, Data-Driven & Lean

IntePros; Jersey Shore (Lycoming County); On-site; USD 65,000 - 90,000; Full time

Job summary

IntePros is seeking a Quality Engineer to join a growing medical device manufacturing client in Jersey Shore, PA. You will be hands-on and contribute to continuous improvement, measuring data, implementing corrective actions, and improving products and processes.

The role involves QA/QC, Process Engineering, and Production support across site and corporate levels, with significant time in production and QC areas and opportunities to drive cross-functional quality initiatives.

Qualifications

• Bachelor’s degree in engineering, Biology, or Business.
• Minimum 1–2 years of quality or engineering experience in a regulated manufacturer.
• Six Sigma Green Belt certification preferred.
• Knowledge of Lean, Six Sigma, DMAIC, PDCA, Root Cause Analysis, Corrective Action.
• Experience with Minitab is highly preferred.
• Experience with programming and/or operation of CNC machine tools or CMMs.
• Experience with SAP ERP is highly preferred.
• Knowledge of ISO 9001, ISO 13485 or 15378, 21 CFR 820, 21 CFR 210 & 211, cGMP.
• Experience auditing processes and products.
• Ability to read and interpret technical drawings.

Responsibilities

• Drive improvement of site and departmental goals of Cost of Poor Quality, Yield Opportunity, etc.
• Provide quality reports and review trending on assigned areas of responsibility
• Work with management and technical staff in performing root cause failure analysis and implementing corrective and preventive actions to preclude recurrence
• Support Lean Six Sigma programs and activities towards delivery of the set targets, and continuous improvement of products, services, and processes
• Participate in the development and maintenance of product/service/process risk and hazard analysis
• Conduct Quality Shop Floor Audits to identify, communicate, and follow‑up on issues that may impact product quality
• Support optical measurement equipment and systems
• Other duties as assigned

Skills

Six Sigma Green Belt

Lean

DMAIC

PDCA

Root Cause Analysis

Corrective Action

Problem Solving

Minitab

CNC / CMM

SAP / ERP

ISO 9001 / 13485

Auditing

Reading drawings

Education

Bachelor’s degree in engineering, Biology, or Business

Tools

Minitab

CNC / CMM

SAP

Job description

IntePros is seeking a Quality Engineer to join a growing medical device manufacturing client in Jersey Shore, PA. You will be hands-on and contribute to continuous improvement, measuring data, implementing corrective actions, and improving products and processes.

The role involves QA/QC, Process Engineering, and Production support across site and corporate levels, with significant time in production and QC areas and opportunities to drive cross-functional quality initiatives.