Quality Engineer 1, Manufacturing

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

Job summary

Cook Group in Bloomington, Indiana is seeking a Quality Engineer. This role involves serving as the lead quality representative for specific product lines in development and manufacturing. Responsibilities include ensuring compliance with quality standards, supporting manufacturing transitions, conducting risk assessments, and driving continuous improvement initiatives. Ideal candidates must have a Bachelor's degree in a scientific field, knowledge of medical device regulations, and proficiency in quality improvement methodologies. Applications from individuals with certifications like ASQ or Six Sigma are encouraged.

Qualifications

• Demonstrates knowledge of medical device regulations and risk management.
• Must be adept in quality assurance processes and tools.

Responsibilities

• Perform work per external and internal quality standards.
• Support product development and transfer to manufacturing.
• Facilitate development and implementation of production controls.
• Conduct risk-based decision making and resolution of issues.
• Drive continuous improvement efforts.

Skills

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

Proficiency in statistical, quality and continuous improvement methods

Strong organizational skills

Critical thinking

Excellent verbal communication skills

Proficiency in Microsoft Office suite

Education

Bachelor's degree in a scientific discipline

Professional certification (e.g. ASQ, Six Sigma)

Job description

Overview

The Quality Engineer at Cook Inc.serves as the lead quality representative of certain product lines within product development, manufacturing, 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 a scientific discipline or equivalent experience
• Demonstrates knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971)
• 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