Cook Medical ยท 2 hours ago
Quality Engineer 2, Manufacturing
Bloomington, IN
Full-time
Onsite
Mid Level
3+ years expCook Medical is a company specializing in medical devices, and they are seeking a Quality Engineer to lead quality initiatives in product development and manufacturing. The role involves ensuring compliance with quality standards, supporting product transfers, conducting investigations, and driving continuous improvement efforts.
HardwareManufacturingMedical Device
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
Qualification
Required
Bachelors degree Biomedical Engineering, Mechanical Engineering, Industrial Engineering
3-5 years of experience
Demonstrates knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971)
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
Preferred
Professional certification (e.g. ASQ, Six Sigma, etc.)
Company
Cook Medical
Cook Medical is a medical device company that specializes in designing, manufacturing, and delivering invasive medical devices. It is a sub-organization of Cook Group.
10001+ employees
H1B Sponsorship
Cook Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2023 (3)
2022 (2)
Funding
Current Stage
Late StageLeadership Team
G
Gayle Cook
Co-founder
Kelly Fischer
Senior Vice President and Chief Financial Officer
Recent News
Company data provided by crunchbase