Quality Assurance Specialist
1 month ago
A highly skilled Quality Assurance Specialist is required to lead design control and risk management activities for combination product development programs. As a key member of our team at Russell Tobin, you will support risk management activities at external design companies and manufacturing facilities, ensuring that combination product development activities are compliant with quality and regulatory standards.
About the Role:
- Lead design control and risk management activities for combination product development programs.
- Support risk management activities at external design companies and manufacturing facilities.
- Ensure combination product development activities are compliant with quality and regulatory standards.
- Provide input to design validation, including human factors engineering assessments.
- Support the assessment of external design companies and suppliers for quality systems, facilities, and procedures.
- Support device design and manufacturing investigations.
- Support regulatory submission data and content generation for assigned device projects.
- Support internal and external audits of the Quality Management System.
Requirements:
- BSc in a relevant science or engineering discipline, with a minimum of 2 years of experience in the pharmaceutical combination product and/or device industries.
- OR MSc in a relevant science or engineering discipline, with a minimum of 2 years of experience in the pharmaceutical combination product and/or device industries.
- OR PhD in a relevant science or engineering discipline, with a history of working in accordance with ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
- Experience in design controls and risk management for combination products.
- Familiarity with Human Factors Engineering - Usability Engineering.
- Familiarity with device assembling manufacturing processes.
Technical Skills:
- Working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
- Familiarity with EN 62366, EN 60601, and EN 62304.
- Able to learn and apply established procedures in a reliable and consistent manner.
- Capable of working independently with minimal supervision.
- High level of attention to technical details and accuracy.
- Able to prioritize multiple responsibilities and to work on multiple tasks simultaneously.
- Able to work collaboratively in cross-functional teams.
- Excellent communication and interpersonal relationship skills.
- Proficiency in general computer software such as word processing, spreadsheets, presentations.
- Understand Good Manufacturing Practices (GMP).
Salary: $80,000 - $110,000 per year
Location: USA
Industry: Medical Devices
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