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Senior Manufacturing Quality Engineer
Company : Cook Medical
Location : Bloomington, IN, 47404
Job Type : Full Time
Date Posted : 2 January 2026
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.- 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 withminimal supervision.- Ability to remain calm and receptive in fast paced situations.
Qualifications
- Engineer degree and 5-8 years of experience- Demonstrates 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 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.
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Frequently asked questions
In Bloomington, certifications like ASQ Six Sigma and CQE are highly regarded among Manufacturing Quality Engineers. These credentials demonstrate proficiency in quality management and process improvement, aligning well with local manufacturing standards and regulatory expectations, thus enhancing career prospects in the region.
Cook Medical attracts a strong pool of candidates for senior quality roles, making the hiring process competitive. Candidates with solid experience in FDA and ISO standards, along with leadership in cross-functional quality initiatives, stand a better chance of securing positions within this innovative medical device company.
Manufacturing Quality Engineers often encounter complex root cause investigations and must balance regulatory compliance with production demands. Addressing non-conformance requires meticulous data analysis and collaboration across departments to implement corrective actions while maintaining product quality and minimizing downtime.
Senior Manufacturing Quality Engineers typically lead strategic quality initiatives and risk assessments, whereas Quality Control Engineers focus more on day-to-day inspection and compliance checks. The senior role demands broader regulatory knowledge and cross-team leadership, especially in regulated sectors like medical devices.
Bloomington’s manufacturing sector often emphasizes adherence to stringent FDA regulations due to the presence of medical device companies like Cook Medical. Engineers here must be adept at integrating ISO 13485 standards with local quality assurance practices, reflecting the region's focus on healthcare product excellence.
At Cook Medical, the culture prioritizes innovation and cross-functional collaboration. Senior Manufacturing Quality Engineers are expected to lead quality improvements while fostering teamwork among engineering, clinical, and regulatory departments, ensuring a unified approach to medical device excellence and compliance.
Senior Manufacturing Quality Engineers in Bloomington typically earn between $85,000 and $110,000 annually. This range reflects local industry standards, the complexity of compliance with medical device regulations, and the seniority of the role within companies like Cook Medical.
Manufacturing Quality Engineers excel in risk management, regulatory compliance (FDA 21 CFR 820, ISO 13485), and continuous improvement methodologies. Their expertise in statistical analysis and root cause investigation sets them apart from roles focused solely on production or design.
Collaborating effectively with engineering, production, clinical, and regulatory teams is crucial for driving quality initiatives. Experience in navigating diverse groups enhances problem-solving, accelerates issue resolution, and ensures compliance across all product lifecycle stages.
Cook Medical encourages continuous professional growth through exposure to cutting-edge medical device projects and regulatory challenges. Senior engineers benefit from leadership roles in quality system enhancements and risk management, paving the way for advancement into managerial or global quality positions.