Quality Control Process Improvement Specialist

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.

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.

Bachelors 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.