Job Description:
We are seeking a Senior Quality Systems Engineer to join our client, a global leader in the medical device industry.
About the Role:
This is an exciting opportunity to contribute to critical quality and compliance initiatives within a regulated environment.
Responsibilities:
* Represent the Quality function in site management meetings.
* 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.
* Oversee risk documentation and process/software validation with significant business impact.
* Lead investigations into non-conformances (NCs) and corrective and preventive actions (CAPAs).
* Ensure compliance with regulatory requirements, including ISO 13485 and FDA standards.
* Conduct internal and supplier audits and participate in external regulatory body audits.
Requirements:
* Bachelor's Degree or higher 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.