Distribution Quality Engineer

Job description

We are currently recruiting for an experienced Distribution Quality Engineer to join the EMEA Distribution Quality team. This position offers an excellent opportunity for a quality-driven professional to expand their experience within a highly regulated medical device environment. The role will focus on quality assurance, regulatory compliance, distribution oversight, and continuous improvement activities across distribution centres, service and repair facilities, and third-party distributor networks.

Key Responsibilities

• Support post-market quality assurance programmes, policies, procedures, and controls relating to medical devices, combination drug/device products, filtration products, and finished goods
• Oversee warehousing, storage, distributor operations, and service and repair activities throughout the EMEA region
• Lead and support continuous improvement initiatives to maintain compliance across internal distribution centres, service and repair sites, and external distributors
• Ensure adherence to global quality and regulatory standards including US 21 CFR 210, 211 and 820, ISO 13485, ISO 14971, EU MDR, Health Canada, MHRA, TGA, and other applicable international regulations
• Participate in projects supporting site and country-level quality system compliance, including storage requirements, local language over-labelling, and product ship hold processes
• Collaborate closely with Operations and Supply Chain teams to maintain effective oversight of global distribution and service networks
• Contribute to quality improvement initiatives through process monitoring, root cause analysis, trend evaluation, and issue resolution activities
• Support the ongoing maintenance of quality management oversight processes across global distribution and third-party networks
• Identify potential quality and compliance risks and assist in implementing corrective and preventive actions (CAPAs) where necessary

Skills & Experience

• Bachelor’s degree in Science or a related discipline, or equivalent qualification
• Minimum of 5 years’ experience working within an ISO 13485 regulated medical device environment
• Strong working knowledge of ISO 13485 and Quality Management Systems (QMS)
• Experience managing quality systems within distribution centres (DC/3PL), distributor networks, and service & repair operations
• Good understanding of international medical device quality and regulatory requirement