Senior Quality Manufacturing Engineer

Cook Medical; Bloomington (IN); On-site; USD 80,000 - 100,000; Full time

Job summary

Cook Medical in Bloomington, Indiana is seeking a Senior Quality Manufacturing Engineer to serve as the lead quality representative for certain product lines. This role includes ensuring compliance with quality standards and facilitating continuous improvements in manufacturing processes.

The ideal candidate will have an engineering degree, 5-8 years of relevant experience, and knowledge of medical device regulations. Responsibilities include managing product quality investigations and working with various teams to uphold quality standards.

Qualifications

• 5-8 years of experience in quality engineering.
• Knowledge of FDA regulations and risk management.
• Proficiency in statistical and quality improvement methods.

Responsibilities

• Lead quality representation in product lines in manufacturing.
• Perform investigations of product non-conformance and root cause analysis.
• Facilitate the development and implementation of production controls.

Skills

Engineering

Quality Management

Problem Solving

Communication Skills

Statistical Methods

Education

Engineer degree

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

Tools

Microsoft Office Suite

Job description

Senior Quality Manufacturing Engineer

Overview

The Quality Engineer serves as the lead quality representative of certain product lines within manufacturing.

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 non‑conformance/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.
• Maintain all training requirements for the position while seeking opportunities for continuous development and growth.
• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
• Work and interact effectively and professionally with others throughout various levels of the global organization.
• Strictly adhere to safety requirements.
• Maintain regular and punctual attendance.
• Maintain company quality and quantity standards.
• Have effective communication skills and the ability to work collaboratively and independently with minimal supervision.
• Remain calm and receptive in fast‑paced situations.

Qualifications

• Engineer degree and 5‑8 years of experience.
• 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 Microsoft Office suite (Word, Excel, PowerPoint, Outlook) required.
• Strong organizational skills.
• Critical thinking and attention to detail required.
• Excellent verbal communication skills and technical writing.

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.