A leading medical device company manufactures high-value packaging and components for the medical devices industry. They seek a committed Validation Engineer to support validation activities.
About Us
The company has a proven track record in producing high-quality products with world-class product design expertise, manufacturing excellence, and a strong strategic global footprint. They are expanding their production facility due to high demand.
Your New Job
* Write and execute process validation protocols and reports for new product introductions and revalidation.
* Maintain compliance to ISO 13485 and ISO 14001 systems standards.
* Incorporate solutions to sustain and improve the Quality Management System (QMS).
* Foster continuous improvements through Lean Six Sigma methodologies.
* Support Good Manufacturing Practice (GMP) and regulatory audits.
* Review and execute Factory Acceptance Testing and Site Acceptance Protocols.
* Prepare and deliver training modules as required.
* Sustain Continuous Improvement through Lean Six Sigma methodologies.
What We Are Looking For
* A third-level qualification in an engineering discipline or Polymer science is required.
* Three to five years of experience as a Validation Engineer in an injection moulding/medical device background is necessary.
* Experience in statistical analysis (Minitab)/ Statistical Process Control (SPC)/ Validations is essential.
* Candidates must be influential and proactive in their approach to daily duties.
* Strong attention to detail and a hardworking competency are expected.