Quality Assurance Director
- Location: Atlanta, Georgia
- Working Situation: Hybrid
- Level: Senior level
Our client, a mid-sized, medical device firm, Working on Class-1 to Class-3 Medical devices
The Director- Quality Assurance will oversee all quality operations for their specific site. The job includes creating, implementing, and maintaining Quality Operations and procedures for the facility. In this role, standards, methods, and processes for testing and assessing goods and raw materials are developed and put into practice.
The Director- Quality Assurance will:
- Develop and execute Quality Assurance Continuous improvements for the site.
- Monitor the GMP systems currently in place to ensure compliance with documented policies.
- Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
- Monitor and trend data while assembling reports on product release test monitoring of company cGMP facility.
- Frequently update stakeholders on trends.
- Implement corrective action plans when vital.
- Tracking of data from external contract manufacturers and laboratories to complete lot disposition.
The Manager - Quality Assurance has the following qualifications:
- 4+ years of people management experience (required).
- 8+ years of experience working with quality management system (desired).
- Master's Degree with relevant fields with 4+ years of medical device/biotech industry experience.
- Competitive 401K program, health insurance, and HSA accounts.
- Long term incentives in the terms of equity or stock at this level.
- Relocation assistance provided for non-local candidates.