What are the responsibilities and job description for the Assistant Quality Manager position at Element2 Group?
Overview
We are seeking a dedicated and detail-oriented Assistant Quality Manager to support the quality assurance and control processes. The ideal candidate will be responsible for ensuring compliance with industry standards, particularly FDA regulations, while leading efforts to enhance product quality and operational efficiency. This role is crucial in maintaining the integrity of our products and ensuring customer satisfaction through effective quality management practices.
Duties
- Develop, implement, and maintain quality management systems in accordance with ISO 13485 standards.
- Conduct regular quality inspections and audits to ensure compliance with internal and external standards.
- Lead projects aimed at improving quality control processes and enhancing product reliability.
- Analyze data from quality inspections and audits to identify trends and areas for improvement.
- Collaborate with cross-functional teams to address quality issues and implement corrective actions.
- Train and mentor staff on quality assurance best practices and regulatory requirements.
- Prepare detailed reports on quality metrics, findings from audits, and recommendations for improvements.
Must Haves:
- 3-5 years of QC documentation
- Must have direct experience working in ISO 9001 and 13485
- Must comply all SOP and work instructions/drawings are in compliance with both standards (ISO 9001 and 13485)
- CAPA experience (Corrective and Preventative Action)
- MDR (Medical Device Regulations)
Job Type: Full-time
Pay: $28.00 - $32.00 per hour
Schedule:
- 10 hour shift
- 8 hour shift
- Monday to Friday
Work Location: In person
Salary : $28 - $32
