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Senior regulatory compliance specialist

Athlone
beBeeQuality
Compliance specialist
Posted: 13 August
Offer description

Regulated Quality Expert Wanted

We are seeking a talented Quality Engineer to join our team on a 12-month contract. This role is perfect for an experienced quality professional who wants to expand their skills, work on high-profile projects, and gain exposure in a regulated environment.

* Lead quality improvement initiatives to enhance processes, reduce costs, and ensure regulatory compliance.
* Support change controls, risk assessments, and process validations.
* Analyse data and spot trends using statistical tools.
* Write and review CAPAs, non-conformance reports, and supplier corrective actions.
* Conduct audits and support inspections by ISO and FDA regulators.

What You'll Need:

* 3+ years' experience in a regulated environment - ideally medical devices or FDA/ISO 13485 certified manufacturing.
* Degree in Quality, Science, or Engineering.
* Strong MS Excel, Word, and Power Point skills.
* Experience with FMEAs, root cause analysis, and statistical analysis.
* Excellent attention to detail and problem-solving ability.

Key Skills: Quality Manager, Communication, CAPA

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