Senior Quality Engineer

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