Manager, Quality Compliance

As a Manager, Quality Compliance you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Support quality system inspections/audits with preparation, execution, and associated documentation. Includes participation in different roles such as front room coordinator, back room lead, scribe, document retriever, and quality reviewer.
• Performs root cause investigations with identification of associated corrections, corrective actions, and preventive actions.
• Ensure Trackwise Quality Management System is maintained, that relevant data are entered timely, consistently and accurately
• Act as assessor and/or approver of medical device reporting decisions. Write and/or review associated medical device initial, follow up, and final reports to health authorities.
• Identify, develop, and/or support process/procedure improvements for various quality system including, but not limited to, complaint handling, device vigilance, deviations, CAPAs, etc.
• Create, improve, and maintain general quality management systems tools, job-aids, and documentations.
• Act as Trackwise subject matter expert for complaint handling and vigilance procedures/processes.
• Conduct gap assessments to changing global medical device and combination product regulations, standards, and guidance.

You are:

• BS in a scientific or allied health/medical field (or equivalent degree).
• Minimum of 1-2 years of quality experience, preferably in the medical device and combination product field.
• Basic knowledge of pharmaceutical, medical device, or combination product development and lifecycle management.
• Fluency in written and spoken English, additional language skills a plus.
• Basic technical writing skills including use of Word and Excel.

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.