Leadership Role in Quality Control
The primary goal of this position is to lead a team of Quality Control Inspectors in a production environment, ensuring compliance with quality standards and regulations.
Reporting directly to the Manager, Quality Control.
Key Responsibilities
* Quality Control Oversight: Responsible for inspecting medical devices at various stages, including raw materials, in-process products, finished, and sterilized devices within Cook Medical.
* Compliance Assurance: Ensure that quality control personnel adhere to established quality system requirements.
* SOP Development: Prepare or review Standard Operating Procedures (SOPs) for manufacturing and quality control instructions necessary for the quality team.
* Cleanliness Maintenance: Maintain a high standard of cleanliness in manufacturing areas to control product bio burden.
* Procedure Updates: Communicate changes to relevant procedures or instructions to production teams affected.
* Employee Training: Regularly review training needs for employees in the QC area and provide necessary training.
* Performance Management: Monitor employee performance and conduct performance appraisals as required.
* Interdepartmental Collaboration: Foster excellent communication channels with production teams and other departments.
* Customer Focus: Take ownership of assigned customer complaints, CAPAs, and determine root causes.
* Process Monitoring: Track rejects from quality control processes and disposition through the MRB process.
Requirements
* Education: Level 8 in Manufacturing Engineering or related discipline preferred.
* Experience: Minimum 5 years of supervisory experience desirable.
* Soft Skills: Strong communication and interpersonal skills.
* Knowledge: Familiarity with medical device quality standards (ISO13485/FDA practices), GMP, and regulated industry standards.
* Computer Literacy: Proficiency in Microsoft Office and ability to learn new software systems.
* Organizational Skills: Excellent organizational and team-building abilities.
* Motivation: High self-motivation and willingness to travel on company business.