Cook Medical · 13 hours ago
Quality Control/ Process Improvement Specialist
West Lafayette, IN
Full-time
Hybrid
Entry Level
3+ years expCook Medical is a company that supports a cross-functional team of engineers, scientists, and other professionals on various projects. The Quality Control/Process Improvement Specialist will perform quality control activities, support various groups, and assist in process improvement initiatives to ensure compliance with regulations and standards.
HardwareManufacturingMedical Device
No H1B
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
Use project management skills to help organize work tasks, milestones, and due dates for multiple concurrent projects
Qualification
Required
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
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
Company
Cook Medical
Cook Medical is a medical device company that specializes in designing, manufacturing, and delivering invasive medical devices. It is a sub-organization of Cook Group.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
G
Gayle Cook
Co-founder
Kelly Fischer
Senior Vice President and Chief Financial Officer
Recent News
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