Specialist, Quality Engineering

Cook Group•Richland, IN

About The Position

The Quality Engineering Specialist supports, reviews, and analyzes quality system processes. The role works with an interdisciplinary team of engineers and other specialties, as well as the department, to advance the strategic goals of Quality Engineering. The specialist drives and organizes quality projects and improvement initiatives, investigates quality issues, monitors processes critical to the CMLLC Quality Management System, and participates in internal and external quality assessments and audits. The role requires maintaining relevant documentation and systems, understanding applicable regulatory requirements, and adhering to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable requirements. The specialist works collaboratively across departments and organizational levels, communicates project progress and issues, and provides feedback to management. The role also requires maintaining training, meeting quality and quantity standards, following safety requirements, and maintaining regular and punctual attendance.

Requirements

1–2 years of Quality Assurance or relevant experience.
Knowledge of medical device regulations, including pertinent standards.
Computer literacy and proficiency.
Understanding of regulatory requirements.
Effective communication skills and ability to work collaboratively and independently with minimal supervision.

Nice To Haves

Experience in statistical and analytical reasoning.
CQA or similar certification.
Bachelor's degree in a technical field or equivalent experience.
Knowledge of Cook quality systems, associated documentation, and product lines.

Responsibilities

Drive project improvement initiatives with minimal oversight.
Monitor and report project progress, delays, and completions, involving management at appropriate times.
Investigate quality issues.
Communicate with other departments to identify and troubleshoot project issues.
Provide management with feedback on areas for improvement from systems and personnel perspectives.
Monitor and maintain processes critical to the CMLLC Quality Management System.
Participate in internal and external quality assessments and audits.
Independently produce, organize, and maintain documents or systems critical to the department.
Lead short-term, long-term, or system-forward projects.
Organize and participate in quality projects.
Maintain training requirements and seek 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.
Interact effectively and professionally with people throughout various levels of the global organization.
Strictly adhere to safety requirements.
Maintain regular and punctual attendance and company quality and quantity standards.
Communicate effectively and work collaboratively and independently with minimal supervision.
Remain calm and receptive in fast-paced situations.
Multi-task.