What are the responsibilities and job description for the Quality Engineer position at Compunnel Inc.?
Exciting Opportunity for a Quality Systems Professional
Are you passionate about ensuring high standards in quality management systems? Do you thrive in a collaborative environment where your expertise drives continuous improvement? We are looking for a detail-oriented and proactive Quality Systems Specialist to join our team and play a key role in optimizing our Quality Management System (QMS) and ensuring regulatory compliance.
Key Responsibilities :
- Document & Process Excellence : You will be at the forefront of generating, reviewing, and maintaining division-level quality documents such as procedures, work instructions, job aids, and certificates of conformance, all while ensuring strict compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards.
- Change Control & Process Optimization : Lead the initiation of Change Controls and Document Change Requests to keep our procedures up to date. You will collaborate closely with manufacturing and distribution teams to assess and implement process changes efficiently.
- Audit Leadership : Take the lead in conducting internal audits, ensuring our systems are operating smoothly and in full compliance with all regulations.
- Continuous Improvement : Use your expertise in root cause analysis to drive corrective and preventive actions (CAPAs) and spearhead continuous improvement initiatives to enhance the efficiency and effectiveness of our QMS.
- Regulatory Support : Be an essential part of our team by supporting regulatory activities and contributing to quality system projects and metrics analysis.
What We’re Looking For :
What We Offer :
