Overview

The Quality Control/Process Improvement Specialist supports a cross functional team of engineers, scientists, and other professionals on various projects; including support of product submissions, document review, process improvement activities, problem -solving expertise, and to help ensure compliance with pertinent regulations and standards.

Responsibilities

Perform quality control (QC) activities to ensure protocols, reports, project data and documentation, validation documentation, and technical reports are accurate, complete, and compliant with Quality System, and applicable regulations and standards by reviewing, identifying, and correcting discrepancies;

Interact with and support various groups, locally and globally, across Cook Medical; including Engineering, Regulatory Science, Regulatory Affairs, Biocompatibility, Material Science, and Toxicology;

Provide responsive and proactive organizational and administrative support to team members and collaborator requests;

Provide critical review of technical and scientific documents for clarity, consistency, and flow;

Maintain a working knowledge of relevant QMS processes and procedures, regulations (e.g., EU MDR), and standards (i.e., ISO 10993, ISO 17025, etc.);

Assist in preparation of resources and documents, including SharePoint;

Apply problem solving expertise to help gain efficiencies in various project tasks;

Assist team members and collaborators in procuring documentation to facilitate project tasks and goals;

Work with the Process Improvement Manager and other stakeholders/teams being supported to identify, propose, and implement process improvement initiatives; and

Use project management skills to help organize work tasks, milestones, and due dates for multiple concurrent projects.

Qualifications

• Bachelor's degree in a technical discipline or 3 years of relevant experience
• Interest in a career in the Life Sciences, Engineering, Technical/Professional Writing, or related fields, have a willingness to take initiative, and have an ability to work well with others
• Detail oriented
• Effective written and oral communication skills
• Working knowledge of Good Laboratory Practice (GLP), ISO 13485, and ISO 17025

• Good grammar and spelling
• Ability to manage multiple projects along with changing priorities
• Ability to handle conflict in a professional and calm manner
• Proficiency with Microsoft Office (e.g., Word, PowerPoint, Excel, SharePoint)

• This position is a hybrid position, which requires regular on-site visits, minimum 2-3 times per week; and

• Qualified candidates must be legally authorized in the United States. Cook does not intend to provide sponsorship for employment visa status' for this employment position.