Quality Engineer 2, Manufacturing

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

Job summary

Cook Medical in Bloomington, Indiana is seeking a Quality Engineer 2 to serve as the lead quality representative within product development and manufacturing. The successful candidate will support quality standards, facilitate production controls, and engage in risk-based decision making. Applicants should have a bachelor's degree in engineering and 3-5 years of experience, with knowledge of medical device regulations. The position may require occasional travel and provides opportunities for continuous professional development.

Qualifications

• 3-5 years of experience in a relevant field.
• Professional certification (e.g. ASQ, Six Sigma) preferred.
• Ability to manage conflict resolution in technical situations.

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.
• Drive continuous improvement efforts collaborating with cross functional teams.

Skills

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

Proficiency in statistical, quality and continuous improvement methods

Excellent verbal communication skills

Critical thinking and attention to detail

Strong organizational skills

Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook)

Education

Bachelors degree in engineering

Job description

Quality Engineer 2, Manufacturing

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 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

We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class. Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.