Quality Systems Engineering Manager - Design
Location: Galway, County Galway, Ireland.
Job Type: Full-time.
Responsibilities
Drive compliance and achievement of the company's quality objectives.
Support implementation of NPI processes and systems, enhancing quality and efficiency to drive continuous improvement and consistently deliver safe and effective products.
Implement and maintain Lean Product Development processes.
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 that 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.
Qualifications
Primary degree qualification in a science, engineering or other technical discipline.
Minimum 5+ years' experience in the Medical Device industry.
Experience in establishing and maintaining all aspects of QMS.
Cleanroom management and validation, sterilisation 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.
Benefits
Bike to work scheme
Company events
Company pension
Employee assistance program
On-site parking
Private medical insurance
Sick pay
Senior Level
Mid-Senior level.
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