Job Description
Role Summary
As a Senior Quality Engineer, you will play a key role in ensuring the quality activities of our organization are fit for purpose and consistently meet both internal and external requirements. This includes remaining up-to-date with ISO and FDA regulations to ensure the company is audit-ready.
Main Responsibilities
* Develop and maintain processes in compliance with QMS and customer requirements.
* Support and lead teams during QMS investigations, providing review and approval of associated reports and actions in a timely manner.
* Participate in and lead (if required) external audits/inspections, including Notified Body Audits, Customer Audits, and Regulatory Inspections.
* Maintain Quality Metric Logs related to Quality Operations.
* Support the HR department with Training Management and reporting of associated metrics.
* Lead improvement initiatives relating to Quality and Compliance across the site in conjunction with associated departments.
About You
* 5+ years of quality experience in a regulated environment, preferably contract manufacturing.
* A minimum of 3 years' U/HPLC experience within a GXP Laboratory environment.
* Experience in Quality Systems Development and Management.
* Experience leading and developing teams.
Benefits
* Competitive salary: €65k.
* Pension scheme.
* Health insurance.
* Performance bonus.