Industry : Medical Device
The Quality Specialist is a member of the Quality department and plays a key role in ensuring that the Quality System functions are maintained in compliance with documented procedures and applicable regulatory standards. The Quality Engineer supports design transfer activities to ensure on-going compliance and continuous improvement. The position reports to the Quality Manager.
Role Responsibilities and Duties:
- Provide compliance oversight and guidance for design transfer activities, as assigned.
- Maintain awareness of applicable quality standards that regulate our industry. Maintain vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.
- Support and lead the review and approval of related design records.
- Support and/or lead the development and update of associated Risk Management files.
- Ensure compliant documentation, carrying out tasks related to area of responsibility with management oversight.
- Support and/or lead product and process improvement activities from a quality perspective, ensuring supporting information/rationale for change including reasons and justifications is acceptable.
- Contribute to defining and timely achievement of overall design transfer project goals related to design control from transfer through product launch as assigned.
- Support and lead the development and implementation compliant solutions to problems/issues arising during design transfer/control activities, ensuring appropriate documentation of the event and subsequent resolution from a CAPA perspective.
- Provide guidance on IVDR related requirements.
- Involved in Complaint activities which support and guide in discharging regulatory obligations to conduct Complaint Handling, Vigilance Reporting and Post Market Surveillance activities.
- Excellent interpersonal, written and verbal communication skills, including ability to convey appropriate information with clarity and effectiveness.
- Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.
- Proficient with MS Word, Excel, Power Point, and management of spreadsheets.
- Competent working knowledge of recognized Quality Management Systems and Global Medical Device regulations (e.g., ISO9001/ ISO13485/ ISO14971/ cGMP / CE/ FDA/ PAL/IVDR/MDSAP).
- Experience with IVDR requirements an advantage.
Role Education & Experience:
- Third level qualification in Science/ Engineering.
- Minimum 5 years of experience in medical device industry with minimum 3 years of progressively responsible positions.
- In Vitro Diagnostics experience would be an advantage
- Design Transfer experience would an advantage.
Duration: 12-month fixed term contract. The role would be hybrid, typically 3 days a week onsite and 2 days remote