Senior Quality Systems Engineer
We are seeking a Senior Quality Systems Engineer to contribute to critical quality and compliance initiatives within a regulated environment.
Responsibilities:
* Represent the Quality function in site management meetings and act as a delegate for the Quality Lead when required.
* Lead quality systems software validation activities across the site.
* Drive process improvements and cost-saving initiatives using data analysis and quality tools.
* Develop and manage project plans, including resource allocation and technical activities such as procedural updates and test methods.
* Oversee risk documentation and process/software validation with significant business impact.
* Lead investigations into non-conformances (NCs) and corrective and preventive actions (CAPAs), providing technical guidance to teams.
* Ensure compliance with regulatory requirements, including ISO 13485 and FDA standards.
* Conduct internal and supplier audits and participate in external regulatory body audits.
* Collaborate with cross-functional teams to implement robust quality solutions.
* Provide guidance on quality and engineering processes to address compliance issues.
Requirements:
* Bachelor's Degree or higher (Level 8) in Engineering or Science.
* Minimum of 5 years of experience in a regulated environment, ideally in the medical device sector.
* Demonstrated expertise in ISO 13485 and FDA regulatory environments.
* Certification as a Lead or Internal Auditor is an advantage.