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Quality Engineering Manager, CAPA
Company : Cook Medical
Location : Bloomington, IN, 47404
Job Type : Full Time
Date Posted : 3 January 2026
Overview
The Quality Engineering Manager serves on a cross functional team, ensuring the adequacy, suitability and compliance of specified Quality Management System processes. Manages day-to-day quality operations and provides leadership and direction to the functional team. In addition to CAPA, this position is expected to provide leadership, oversight, and or monitoring for other Quality Systems such as Nonconformance Investigation/Containment and Field Action Assessment Request.
Responsibilities
- Approve quality documents, analyze improvement of the QMS and other department processes, including reviewing, updating, creating, and implementing SOP’s to support improved processes and compliance.- Provide quality expertise and both direct and indirect cross-functional leadership to management and operational personnel.- Responsibility and authority for ensuring that processes needed for the quality management system are documented; reporting to top management on the effectiveness of the process(es) and the need for improvement; promoting the awareness of applicable regulatory and quality management system requirements throughout the organization.- Prepare, communicate and monitor quality plans and metrics.- Maintain the process in the Quality Management System to ensure meeting FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.- Participate in hiring, interviewing and onboarding process of new hires.- Responsible for performance management and annual reviews of direct reports.- Attend, present and provide data for meetings to include project updates and reviews.- Authorization of weekly time sheets, concur, PTO request, department specific documents.- Manage the CAPA process and associated personnel both inside and outside fo the function in order to ensure swift, effective, compliant corrective and preventive actions- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.- Adhere to the Quality Management System to ensure meeting FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements, driving quality throughout the organization.
- 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
- Minimum of 5 years experience in an FDA-regulated industry, preferably in a medical manufacturing environment.- Minimum 5 years experience working with quality management system.- Previous leadership experience, 5 years preferred.•Bachelor's degree in Engineering or Life Science- Proficient in Microsoft Word/Excel/Project/Outlook, JBase, Livelink, Business Objects.- Experience in project management required, 5 years preferred- Experience in root cause analysis and corrective action required, 5 years preferred
- Works under general office environment conditions.- Utilizes close visual acuity for working with computers and equipment.- Frequently required to stand, walk, and hear.- Occasionally lifting with minimal exertion during shift.
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Frequently asked questions
In this capacity, the manager ensures all corrective and preventive actions align with FDA 21 CFR 820 and ISO 13485 standards. Their oversight guarantees that quality processes meet regulatory demands, minimizing risks and supporting Cook Medical's commitment to stringent medical manufacturing quality.
Strong communication, decisive problem-solving, and cross-functional collaboration skills are vital. The manager must inspire and guide teams through complex quality challenges, fostering accountability while maintaining regulatory compliance and continuous process improvements.
Expertise in root cause analysis, proficiency with quality management software, and solid knowledge of FDA and ISO regulations are crucial. Additionally, competency in Microsoft Office Suite and project management tools supports effective oversight of CAPA and quality systems.
Bloomington's medical manufacturing sector is growing, elevating demand for quality engineers. However, Cook Medical's reputation attracts seasoned candidates, making competition stiff. Candidates with strong regulatory experience and leadership skills stand out in this competitive environment.
Certifications such as CQE (Certified Quality Engineer) or Six Sigma are highly regarded locally. Given the FDA-regulated environment, credentials demonstrating expertise in quality systems and CAPA processes can significantly boost candidate attractiveness at Cook Medical.
Cook Medical emphasizes a cross-functional approach, integrating CAPA leadership with broader quality system oversight. The role involves not just managing quality operations but actively shaping compliance strategies within a leading medical device firm renowned for innovation.
Cook Medical fosters a collaborative and safety-conscious environment. This culture demands that managers lead by example in maintaining compliance and quality standards, while promoting continuous personal and team development within a fast-paced, regulated setting.
Based on current market data, professionals in this role typically earn between $95,000 and $130,000 annually in Bloomington. Variations depend on experience level, leadership scope, and proficiency with regulatory standards such as FDA and ISO requirements.
Navigating complex root cause analyses under tight regulatory deadlines is common. Balancing swift corrective actions while ensuring thorough documentation and cross-departmental coordination challenges managers to maintain compliance without compromising production timelines.
One misconception is that CAPA management is purely administrative. In reality, it requires strategic thinking, leadership, and technical expertise to drive systemic improvements and prevent recurrences, directly impacting product safety and company compliance.