Specialist, Quality Engineering
Cook Group
Summary
The Quality Engineering Specialist supports, reviews, and analyzes quality system processes and works with an interdisciplinary team of engineers and specialties along with their department to advance the strategic goals of Quality Engineering.
Job description
Overview
The Quality Engineering Specialist supports, reviews, and analyzes quality system processes and works with an interdisciplinary team of engineers and specialties along with their department to advance the strategic goals of Quality Engineering.
Responsibilities
- Drives project improvement initiatives with minimal oversight.
- Monitor and report project progress, delays, and completions while involving management at the appropriate times.
- Investigate quality issues.
- Communicate with other departments to identify and troubleshoot project issues.
- Provide feedback to management on areas for improvement from a systems and personnel standpoint.
- Monitor and maintenance of processes critical to CMLLC Quality Management system.
- Participate in internal and external quality assessments/audits.
- Must be able to multi-task.
- Independently produce and organize and maintain document or systems critical to the foundation of the department.
- Lead short term, long term, or system forward projects.
- Organize and participate in quality projects.
- Understanding of regulatory requirements.
- 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.
Qualifications
- 1-2-years of Quality Assurance or relevant experience.
- Knowledge of medical device regulations, including pertinent standards.
- Computer literacy and proficiency.
- Experience in statistical and analytical reasoning preferred.
- CQA or like certification preferred.
- Bachelor's degree in a technical field or equivalent experience preferred.
- Knowledge of Cook quality systems, associated documentation and product lines preferred.
Requirements
- 1-2 years of Quality Assurance or relevant experience
- Knowledge of medical device regulations, including pertinent standards
- Computer literacy and proficiency
- Experience in statistical and analytical reasoning preferred
- CQA or like certification preferred
- Bachelor's degree in a technical field or equivalent experience preferred
- Knowledge of Cook quality systems, associated documentation and product lines preferred
Company overview
Cook Group is a global, family-owned medical device conglomerate founded in 1963 by Bill and Gayle Cook. Headquartered in Bloomington, Indiana, the company has grown from manufacturing three simple medical devices into a diversified corporation with operations spanning medical devices, life sciences, property management, and hospitality services. The core business, Cook Medical, specializes in developing and manufacturing minimally invasive medical devices for various medical specialties including interventional radiology, cardiology, urology, and gastroenterology. With over 10,000 employees worldwide and operations in 135 countries, Cook Group generates approximately $2.3 billion in annual revenue. The company is renowned for its innovative approach to medical technology, recently launching an iMRI division focused on developing MRI-compatible devices for radiation-free interventional procedures. As a privately held entity, Cook Group maintains a long-term strategic focus on patient-centered innovation while diversifying into complementary business sectors that support its mission of improving patient outcomes through less invasive treatment options.