Roles Responsibilities:
- Drive compliance and achieve companies’ quality objectives
- Support implementation of NPI processes and systems, enhancing quality and efficiency to drive continuous improvement to consistently deliver safe and effective product
- Implement and maintain Lean Product Development process
- Support the development of test strategies and methods, complete protocols, testing and reports supporting design, VV (including Sterilisation Validation, Packaging Validation, Biocompatibility and Process Validations)
- Support quality system including management review process
- Support design control, change control, CAPA, risk management and document control systems
- Maintain an effective QMS that complies with the appropriate ISO and FDA standards and requirements
- Work closely with project management and customers to deliver projects successfully meet or exceed customer expectations
- Support, develop and mentor engineers and technicians. Assign tasks, coordinate, provide instruction and feedback as required
- Support Customer and Regulatory surveillance and certification audits
Support Internal and supplier audits
Requirements:
- Primary degree qualification in a science, engineering or other technical discipline.
- Minimum 5+ years’ experience in Medical Device industry.
- Experience in establishing and maintaining all aspects of QMS
- Cleanroom management and validation, sterilization validations an advantage.
- Experience working, building and leading effective teams.
- Effective communication with senior management and working with peer leadership teams.
- Customer and audit facing experience in projects and manufacturing product release is a significant advantage.
- Agile, flexible, innovative and strong problem solving skills.
- Experience in NPI processes and systems an advantage.
Experience in CAPA, risk management and document control systems required.
Job Type: Full-time
Benefits:
