What are the responsibilities and job description for the Quality Engineer position at Compunnel Inc.?
Position Overview :
We are seeking a Quality Management Systems Specialist to assist with a major project in Oneonta, focusing on changes to the documentation system and preparing for an upcoming audit. The ideal candidate will have experience in quality management systems, internal auditing, and regulatory compliance, particularly in manufacturing environments.
Key Responsibilities :
- Generate, review, and maintain division-level quality system documents (e.g., procedures, work instructions, job aids, certificates of conformance) in compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards.
- Initiate Change Controls and Document Change Requests to update procedures and processes, collaborating with manufacturing and distribution sites to assess impacts on processes.
- Monitor and assess quality system metrics to ensure compliance.
- Act as the lead auditor for the division’s internal audit program.
- Assist in completing quality projects and use root cause analysis to support the completion of Corrective and Preventive Actions (CAPAs).
- Lead or support continuous improvement initiatives for quality management system processes.
- Assist with regulatory activities.
- Perform other duties as required.
Minimum Qualifications :
Preferred Skills & Experience :
Benefits :
