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We are looking for a Senior Quality Engineer to lead quality initiatives and ensure compliance with ISO and FDA standards.
This role will drive continuous improvement, support New Product Introduction (NPI), oversee validations, and maintain an effective QMS.
You will mentor engineers, manage audits, and collaborate with project teams to deliver safe, high-quality medical devices.
What you'll do
Drive compliance and achieve 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 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
What we're looking for
Primary degree qualification in a science, engineering or other technical discipline.
Minimum 5+ years' experience in Medical Device industry, ideally at senior engineering or management position.
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.
Why join ICST Medical Devices?
At ICST, we believe our people are the key to our success.
We provide an environment where curiosity, innovation, and growth are encouraged — and where you'll have the opportunity to make a real impact in the medical device industry.
If you're driven, eager to learn, and ready to grow your career in a fast-paced and supportive environment, we'd love to hear from you.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Medical Equipment Manufacturing
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