Quality Assurance Officer – QMS, Products

About the role

Fresenius Medical Care is looking for a Quality Assurance Officer (QMS, Products) in Smithfield. The role covers sampling and testing of products, supporting the quality system so that all activities meet GMP guidelines, NID regulations and ISO standards, and assisting in quality management systems, non-conformance handling and product introduction.

Key responsibilities

• Carry out sampling and testing of packaging materials, raw materials, intermediate products and finished products according to standard operating procedures, and send samples to approved contract testing laboratories.
• Prepare solutions and reference standards, approve chemical reagents before use, and check the calibration status of laboratory equipment against the calibration schedule.
• Record laboratory data on the correct forms in real time, keep retention samples stored properly and notify the QA Manager or Lab Supervisor of out-of-specification results immediately.
• Only approve products for further processing that test within specification, and advise the lab supervisor of low stock materials.
• Perform stability testing on haemodialysis solutions and assist in internal audits for compliance with FMC quality systems.
• Assist in developing and maintaining quality systems, specifications, SOPs and other quality documents, and in non-conformance and deviation management.
• Support the establishment of quality plans and site QMS for Smithfield, keeping ISO and EU MDR certification in place for Smartbags and Procedure Packs.

Required profile

• Tertiary qualification in a relevant scientific discipline or equivalent.
• At least 1 year of experience in a GMP, medical devices and/or ISO certified environment.
• Good English literacy and numerical skills.

Required skills

• Excellent written and verbal communication skills.
• Computer literacy.
• Ability to manage a high throughput of work while meeting quality and business requirements and deadlines.