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Quality Manager
Elk Grove Village, IL 60007 US
Job Description
Responsibilities:
- Lead the Quality Department and work collaboratively with other departments.
- Manage and maintain ISO-9001, GMP, and ISO-13485 QMS.
- Lead annual audits and oversee the Quality team.
- Support the development and execution of quality control standards, policies, and procedures in compliance with 21 CFR Part 820.180 & 820.198 / GMP requirements for Class 1 Exempt Medical Devices.
- Mentor and manage a team of quality control engineers, technicians, and inspectors.
- Collaborate with Operations, Manufacturing, Sourcing, Sales, and Engineering to resolve quality-related issues.
- Establish and monitor KPIs to improve product/service quality and efficiency.
- Conduct inspections and audits to identify defects or non-conformities.
- Analyze trends and recommend corrective/preventive actions.
- Support training initiatives to ensure quality standards are understood and followed.
- Work with suppliers and vendors to ensure quality of incoming materials.
- Prepare and present quality control reports to senior management.
Requirements:
- Bachelor's degree in Engineering or related technical field.
- Minimum of 5 years of experience in a managerial or supervisory quality control role.
- Experience with GMP and ISO 13485 audits.
- Strong knowledge of quality control standards, methodologies, and regulations.
- Proven leadership and team management skills.
- Effective communication and ability to work cross-functionally.
- Experience with Microsoft Office (Excel, Word, PowerPoint).
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