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, V&V (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
Bike to work scheme
Company events
Company pension
Employee assistance program
On-site parking
Private medical insurance
Sick pay
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