Manufacturing Quality Engineer II
3 months ago
Cogmedix, a subsidiary of Coghlin Companies, Inc., is seeking a highly skilled Manufacturing Quality Engineer II to join their team. As a key member of the manufacturing quality engineering department, this individual will be responsible for leading and executing daily manufacturing quality engineering efforts in support of manufacturing operations for assigned product accounts.
The ideal candidate will have a strong background in quality engineering, with experience in ISO 13485 certified and cGMP organizations. They will be responsible for providing engineering, operational, and lean manufacturing leadership, as well as mentoring and training personnel. Additionally, they will collaborate with program managers, manufacturing engineers, and other departments to analyze customer ECOs and ensure effective implementation to the production floor.
The successful candidate will have excellent communication and interpersonal skills, with the ability to work effectively with customers and internal departments. They will also have a strong attention to detail and be able to prioritize tasks to align with the goals of the department and organization.
Key Responsibilities:
- Provide engineering, operational, and lean manufacturing leadership
- Lead and execute daily manufacturing quality engineering efforts
- Collaborate with program managers, manufacturing engineers, and other departments
- Train personnel on quality standards and procedures
- Ensure compliance with Cogmedix quality systems and regulatory requirements
Requirements:
- Bachelor's degree in science, engineering, or manufacturing discipline
- 8+ years of related manufacturing experience and technical document control
- 5+ years of professional experience in medical subassembly and finished device manufacturing
- Advanced skills in MS Word, Excel, and PowerPoint
- Lean concepts and Six Sigma Black Belt certification preferred
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