Senior Quality Engineer

ICS Medical Devices; Connacht; On-site; EUR 65,000 - 95,000; Full time

Benefits offered by this job

Bike to work scheme

Company events

Company pension

Employee assistance program

On-site parking

Private medical insurance

Sick pay

Job summary

ICS Medical Devices is seeking an experienced Quality leader to drive compliance and support NPI processes across the product lifecycle. You will maintain Lean development practices, develop test strategies, and ensure robust validation activities including sterilization, packaging and biocompatibility.

You will mentor engineers, coordinate CAPA and risk management, and work with customers and regulatory bodies to meet quality objectives and audits.

Qualifications

• 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 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.

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 and 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.

Skills

Quality leadership

Agile mindset

Problem solving

Communication

Team building

NPI experience

CAPA/risk management

Documentation control

Lean/continuous improvement

Education

BSc in science/engineering or technical discipline

Job description

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

• 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

• Bike to work scheme
• Company events
• Company pension
• Employee assistance program
• On-site parking
• Private medical insurance
• Sick pay