Quality Engineer

Key Responsibilities

• Develop, implement, and sustain effective quality management system (QMS) processes, including the creation and control of procedures, templates, and quality records.
• 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 / [Employer hidden — sign up to reveal] 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.

Skills & Experience

• Experience in Quality Assurance within a regulated industry.
• Proven working knowledge ISO 9001 standards (ISO 13485 is advantageous to have).
• Demonstrated expertise in product and process validation methodologies.
• In-depth understanding of the design and development lifecycle.
• Proficient in conducting internal audits; lead auditor certification is highly desirable.
• Experience in driving continuous improvement initiatives and applying lean methodologies.
• Advanced problem-solving capabilities, including root cause analysis and effective CAPA management.
• Resilient and delivery-focused, with a strong ability to manage change in dynamic environments.
• Demonstrated expertise in the execution of risk management methodologies.

Benefits

• A competitive salary
• Flexible working arrangements
• A generous holiday allowance
• Three days’ paid volunteering leave
• Additional support and benefits through our Everyone is Included Group Inclusion Plan

About the Company

At [Employer hidden — sign up to reveal] Solutions, part of [Employer hidden — sign up to reveal], we are driven by innovation and dedicated to creating an inclusive workplace. We engineer a more efficient, safer and sustainable world. Our technologies play an essential role in critical industrial processes across Food & Beverage, Pharmaceutical & Biotechnology, Power Generation, Semiconductors and Healthcare.