Job Details
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 SpiraxGroup, 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.
When you join us, you will be integrated into a cooperative and encouraging team, participate in challenging yet critical work, and experience ongoing growth opportunities to help you achieve your full potential.
Job Summary
We are seeking a talented and motivated Quality Engineer to join our dynamic team.
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 the 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 environment.
Benefits
* A competitive salary
* Flexible working arrangements
* A generous holiday allowance
* Three days’ paid volunteering leave
* Additional support and benefits through the Everyone is Included Group Inclusion Plan
Diversity and Inclusion
We are passionate about creating inclusive and equitable working cultures where everyone can be themselves and achieve their full potential. We want everyone to be able to make their difference, so we always consider requests for flexible working. We have introduced a range of additional benefits through our Group Inclusion Commitments.
* Gender-neutral parental leave
* 15 days of extra paid caregiver leave
* Paid time off and support for anyone experiencing pregnancy loss or domestic abuse
* Menopause-friendly workplace principles and more
We are also a Disability Confident Committed Employer.
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.
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