Overview
Job Title: Quality Engineer
Location: BioPure - UK - Havant
Location Type: Hybrid
Website: https://www.wmfts.com/en/
Group: https://www.spiraxgroup.com/
Watson-Marlow Fluid Technology Solutions is part of Spirax Group, a FTSE100 and FTSE4Good multi-national industrial engineering Group with expertise in the control and management of steam, electric thermal solutions, peristaltic pumping and associated fluid technologies.
Job Summary
We are seeking a talented and motivated Quality Engineer to join our dynamic team.
Responsibilities
* 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.
* 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 / 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.
Skills/Experience
* Minimum of 3 years’ experience in Quality Assurance within a regulated industry.
* Proven working knowledge of ISO 13485 and ISO 9001 standards.
* Strong ability to engage and communicate effectively with cross-functional stakeholders.
* 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.
* Established track record in driving continuous improvement initiatives and applying lean methodologies.
* Advanced problem-solving capabilities, including root cause analysis and effective CAPA (Corrective and Preventive Action) management.
* Excellent communication, planning, and organisational skills.
* Resilient and delivery-focused, with a strong ability to manage change in dynamic environments.
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
EEO and Application Information
Everyone is Included at Spirax Group. We are an equal opportunity employer committed to fostering an inclusive and diverse workplace. We encourage candidates from all backgrounds to apply. If you require accommodations during the application process, please let us know. We are also a Disability Confident Committed Employer. If you would like to apply using this scheme, please select this option in our application form.
Company Overview
At Watson-Marlow Fluid Technology Solutions, part of Spirax Group, we are driven by innovation and are dedicated to creating an inclusive workplace where everyone is empowered to make a difference. As a world leader in manufacturing peristaltic pumps and associated fluid path technologies for the life sciences and process industries, we offer a wide range of products, including tubing, specialised filling systems and products for single-use applications. Our shared purpose is to create sustainable value for all our stakeholders as we engineer a more efficient, safer and sustainable world. Our technologies play an essential role across diverse industries with customers in 116 countries.
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