Cook Medical · 23 hours ago
Quality Engineer 2
US-IN-Bloomington
Full-time
Hybrid
Entry, Mid Level
2+ years expCook Medical is a prominent company in the medical device industry, seeking a Quality Engineer to join their quality team. This role focuses on ensuring the integrity and compliance of medical devices throughout the product lifecycle, leading quality assurance activities, and supporting continuous improvement initiatives.
HardwareManufacturingMedical Device
Responsibilities
Maintain and improve the Quality Management System (QMS) in accordance with ISO 13485, 21 CFR 820, and other applicable standards
Act as the primary contact for quality issues, interfacing with internal teams and external stakeholders
Conduct risk assessments and develop risk management documentation, including FMEAs
Lead investigations into product non-conformances and complaints, performing root cause analysis and implementing CAPAs
Review and approve change requests, ensuring compliance with quality standards
Collaborate with cross-functional teams to drive quality improvements and product enhancements
Support internal and external audits, providing documentation and ensuring audit readiness
Analyze quality data to identify trends and opportunities for process improvements
Support product lifecycle activities from design to post-market surveillance, addressing product-related risks
Provide guidance and mentorship to entry-level technical staff
Interface with regulatory bodies and third-party auditors, such as FDA and Notified Bodies
Manage conflict resolution related to technical quality issues
Maintain all required training and seek continuous professional development
Ensure compliance with safety policies and maintain a safe work environment
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or a related technical field
2-3 years of experience in quality engineering within a regulated industry, preferably medical devices
Proficiency in statistical analysis, quality tools, and methodologies (e.g., Six Sigma, FMEA)
Strong understanding of medical device regulations (ISO 13485, 21 CFR 820, ISO 14971)
Excellent communication skills, both verbal and written
Strong organizational skills with attention to detail and critical thinking
Project management experience and ability to work independently
Proficiency in Microsoft Office Suite
Preferred
Professional certification (e.g., ASQ, Six Sigma) 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
Company data provided by crunchbase