Quality Engineering Manager Job Description
We are seeking a Quality Engineering Manager to lead critical projects for new production introduction.
1. The successful candidate will support ISO9000/ISO13485 Quality Systems by ensuring alignment with international standards.
2. Ensure all activities meet regulatory requirements.
3. Lead the Quality Engineering Team through daily management and delegation as a key member of the Quality Leadership Team.
4. Support process enhancements using Six Sigma methodologies.
5. Oversee systems related to production support, such as non-conformance and customer complaint analysis.
6. Liaise with key external customers to ensure quality standards meet expectations.
7. Complete Corrective and Preventive Actions in compliance with regulatory standards.
8. Maintain Good Manufacturing Practice (GMP) compliance in Production and Quality Engineering activities.
Requirements:
* At least 5 years in an ISO 9001/13485 environment, preferably in the medical devices or pharmaceutical industry.
* 3 + years in a supervisory role, indicating leadership skills.
* Understanding of Statistical Process Control (SPC) and Six Sigma methodologies.
* Advanced technical writing skills are required.
* Experience with FDA requirements and audits.
* Process validation, sterilization, and cleanroom experience is advantageous.