Quality Engineer

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 currently looking for a Quality Engineer to join on of our growing medical device/manufacturing clients in Jersey Shore, PA. The Quality Engineer will be a hands‑on contributor to our client’s success and culture of continuous improvement. You will be directly involved in measuring and analyzing data, implementing corrective actions, and improving products, services, and processes. A significant amount of your workday will be spent in the production and QC areas. Another key component of this position is supporting cross‑functional corrective actions and continuous improvement projects in QA/QC, Process Engineering, and Production, at the site, intra‑site and corporate levels.

Quality Engineer 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 and contribute to 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

Quality Engineer Additional Responsibilities

• Education
• Bachelor’s degree in engineering, Biology, or Business

Quality Engineer Work Experience

• Minimum of 1 to 2 years’ experience in a Quality or Engineering role at a pharmaceutical, medical device, or other regulated manufacturer

Quality Engineer Preferred Knowledge & Skills

• Six Sigma Green Belt
• Knowledge of Lean, Six Sigma, DMAIC, PDCA, Root Cause Analysis, Corrective Action, Problem Solving
• Experience with statistical processing software (Minitab highly preferred)
• Experience with programming and/or operation of CNC machine tools or CMMs
• Experience with Material or Enterprise Resource Planning (MRP or ERP) system (SAP 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 and documents
• Demonstrate personal initiative and accountability by proposing creative and innovative solutions while actively driving improvement activities forward
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times
• Able to be aware of all relevant SOPs and Company policies related to duties in this Job Description

License and Certifications

• Manufacturing\\Six Sigma Green Belt Certification Upon Hire preferred

Travel Requirements

• 10%: Up to 26 business days per year

Physical Requirements

• Medium-Exerting up to 50lb/22kg of force occasionally and/or up to 20lbs/9kg of force frequently, and/or up to 10lbs/4kgs of force constantly to move objects.
• Additional Requirements
• Ability to learn, understand, and remember normal tasks.
• Ability to hear, speak, and understand conversation in English in a normal tone of voice.
• Must maintain the ability to work well with others in a variety of situations.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Ability to make independent and sound judgments.
• Use written and verbal communication skills to all levels of the organization
• Read and interpret data, information and documents
• Analyze and solve problems
• Observe and interpret situations
• Learn and apply new information or new skills
• Work under deadlines with constant interruptions