Quality Engineer 2, Manufacturing

Cook Group; Bloomington (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

Cook Group is looking for a Quality Engineer in Bloomington, Indiana. The role involves performing quality work per standards, supporting product development, and interfacing on quality issues. Ideal candidates will have a Bachelor's in engineering, knowledge of medical device regulations, and 3-5 years of experience. Responsibilities also include conducting risk assessments and driving continuous improvement efforts among cross-functional teams.

Qualifications

• 3-5 years of experience in quality engineering.
• Professional certification (e.g. ASQ, Six Sigma) preferred.
• Proficient in quality and continuous improvement methods.

Responsibilities

• Perform work per external and internal quality standards.
• Interface with internal and external groups on quality-related issues.
• Support product development and transfer to manufacturing.
• Conduct risk-based decision making and effective resolution of issues.

Skills

Knowledge of medical device regulation (ISO 13485, 21CFR)

Statistical methods and tools

Strong organizational skills

Critical thinking and attention to detail

Excellent verbal communication skills

Education

Bachelor's degree in engineering

Tools

Microsoft Office suite (Word, Excel, PowerPoint, Outlook)

Job description

Overview

The Quality Engineer at Cook Inc.serves as the lead quality representative of certain product lines within product development, m Next anufacturing, post-market surveillance, and/or CAPA.

Responsibilities

• Perform work per external and internal quality standards
• Interface with internal and external groups on quality-related issues
• Support product development and transfer to manufacturing
• Facilitate development and implementation of production controls (e.g. qualification, process capability, sampling plans, validation, etc.)
• Perform investigation of product nonconformance/complaints, root cause analysis, monitoring/trending of process and product, and escalation of identified issues
• Plan, review, and approve change requests
• Execute risk assessment as needed and facilitate development and completion of risk file documentation
• Conduct Risk-based decision making and effective resolution of issues
• Lead or support CAPAs as necessary
• May interface with internal or 3rd party audits (e.g. FDA, Notified Body, etc.)
• Drive continuous improvement efforts through facilitating, leading, and collaborating with cross function teams including quality, engineering, production, clinical, and regulatory affairs.
• Provide leadership in the understanding of medical device regulations and best practices
• Manage conflict resolution as it relates to technical situations
• Must work and interact effectively and professionally with and for others throughout various levels of the organization
• Must strictly adhere to safety requirements

Qualifications

• Bachelors degree in engineering
• Demonstrates knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971)
• 3-5 years of experience
• Professional certification (e.g. ASQ, Six Sigma, etc.) preferred
• Proficiency in statistical, quality and continuous improvement methods and tools
• Proficiency in the Microsoft Office suite of products (Word, Excel, PowerPoint, and Outlook) is required
• Strong organizational skills
• Critical thinking and attention to detail required
• Excellent verbal communication skills and technical writing

Physical Requirements

• Works under general office environmental conditions, including time in manufacturing environment and biohazard lab
• Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
• Occasional travel may be required