The Quality Engineer is accountable for supporting risk management activities for new and sustaining product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and business unit policies, while meeting all design control and other regulatory requirements.
- Provide Risk Management technical expertise through the product life cycle for new and sustaining product development projects and platforms.
- Provide guidance to team on risk management, regulatory and quality engineering policies, principles and best practices.
- Facilitate development and completion of risk management deliverables between systems by collaboratively working with quality, R&D, engineering, marketing and clinical.
- Develop and maintain Risk Management Files according to ISO 14971 and ensure Risk Management Files are updated per defined schedules and frequencies.
Required Skills and Knowledge
- Strong knowledge of Risk Management discipline and must be able to apply quality principles (GMPs, 21 CFR, EN ISO 14971:2012, IEC 60601-1, ISO 13485, EN 62304, IEC 62366, FDA Guidance - Cyber Security, interoperability, assurance cases etc.) to the R&D environment
- Teamwork oriented and ability to lead and influence with proven problem solving skills
- Consistent application of technical principles, theories, concepts and quality sciences / tools and demonstrates knowledge of FDA/ISO requirements
- Excellent communication and writing skills, this role will require writing quality reports and presentations for executive management and auditors
- Bachelor's degree in technical field
- Minimum 5 years experience in leading risk management activities for medical devices including pre and post-market risk assessments
- Strong knowledge of ISO 14971
Sthree US is acting as an Employment Agency in relation to this vacancy.