Cook Medical ยท 1 day ago
Senior Manufacturing Quality Engineer
Bloomington, IN
Full-time
Onsite
Senior Level
5+ years expCook Medical is a leading company in the medical device industry, seeking a Senior Manufacturing Quality Engineer to serve as the lead quality representative for specific product lines. The role involves ensuring compliance with quality standards, facilitating product development, and driving continuous improvement efforts across cross-functional teams.
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 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
Must maintain all training requirements for the position, while seeking out 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
Must work and interact effectively and professionally with and for others throughout various levels of the global organization
Must strictly adhere to safety requirements
Maintain regular and punctual attendance
Must maintain company quality and quantity standards
Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision
Ability to remain calm and receptive in fast paced situations
Qualification
Required
Engineer degree and 5-8 years of experience
Demonstrates knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971)
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.) preferred
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
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