What are the responsibilities and job description for the Director of Quality Assurance position at SureTek Medical?
Direct all Quality Systems/Regulatory activities for Reprocessor of Single Use Devices. Assure operations conform to company requirements and all applicable regulations under 21 CFR 820.
- Responsible for Design, Development and Implementation of an effective Quality Systems in compliance with FDA QSR/cGMP
- Serve as Management Representative with responsibilities for Management Review
- Evaluate and maintain effectiveness of the Quality Systems programs through Internal Audits, Corrective and Preventative Actions and Quality Planning.
- Evaluate effectiveness of Quality Systems for SureTek vendors through product inspections, review and external audits
- Maintain effective documentation control and revision through Engineering Change Order.
- Assist in design and execution of Verification and Validation testing.
- Assist in review of Personnel Qualifications and Training program.
- Assist in new product development and 510(k) submissions with R&D Design Control documentations
- Review process records and acceptance procedures to maintain an effective Lot Release Control
- Manage customer complaint records and assist in complaint investigations and customer communications.
Salary range of $74,000 to $96,000, with excellent benefits and relocation assistance available to well qualified candidate. Female and bilingual (English/Spanish) candidates are highly encouraged to apply.
Job Type: Full-time
Pay: $72,000.00 - $120,000.00 per year
Benefits:
- Relocation assistance
Work Location: In person
Salary : $72,000 - $120,000