Quality Engineer

We are looking for a passionate and skilled Quality Engineer to contribute to our growing success. The Quality Engineer plays a pivotal role within the BioPure team, in ensuring the highest standard of quality across the product lifecycle. This role supports the development, implementation, and continuous improvement of the quality management system (QMS), working collaboratively with cross-functional teams across multiple regions. The successful candidate will act as a subject matter expert in quality engineering, providing guidance on areas such as quality tools, design development, risk management, validation, and quality compliance. They will lead or support the execution of global quality initiatives ensuring alignment with the global quality strategy and industry best practices. The position requires a strong understanding of international quality standards, excellent problem-solving skills, and the ability to influence and drive change in a complex, matrixed environment. Develop, implement, and sustain effective quality management system (QMS) processes, including the creation and control of procedures, templates, and quality record Provide quality engineering guidance and support to New Product Introduction (NPI) projects, ensuring all quality deliverables are completed on time and in compliance with regulatory and internal requirements Work closely with the validation technical SME to ensure effective verification and validation (V V) of new products and processes within the NPI / product lifecycle Champion thorough investigation of nonconformities using our eQMS Quality Event process, including product non-conformances, process deviations, and customer complaints. Drive effective Corrective and Preventive Actions (CAPA) through structured data driven root cause analysis (e.g., 5 Whys, Fishbone, FMEA). Drive improvements in design, product, and process changes by ensuring changes are impact and risk assessed, documented and implemented in line with quality standards. Collaborate with cross-functional teams (Engineering, Manufacturing, Supply Chain, Quality) to implement quality improvements, in line with the BioPure / WMFTS Quality Strategy. Support validation activities by ensuring the development and maintenance of validation protocols, procedures, and documentation in line with global policy and process. Be part of the internal audit team, conducting and generating audit reports to drive process improvements. Provide training, coaching and guidance on quality tools, systems, and best practices to colleagues and stakeholders. Promote a culture of quality, continuous improvement, and risk-based thinking throughout the product lifecycle and across all functions.