Senior Quality Engineer - WMA

About the role

This Role Will Focus On

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.

Responsibilities

• Strong background in managing sterility control and compliance programs.
• 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, and as part of change management 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 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 WMFTS Quality Strategy.
• Support validation activities by ensuring the development and maintenance of validation protocols, procedures, and documentation in line with 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.

Requirements

• Bachelor’s degree in engineering, or a scientific discipline.
• Minimum of 5 years’ experience in Quality Assurance within a regulated industry.
• Proven working knowledge of ISO 14644-1; ISO 13485 and ISO 9001 standards.
• Ability to host or co-host ISO 9001 audits and customer audits.
• 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 organizational skills.
• Resilient and delivery-focused, with a strong ability to manage change in dynamic environments.

Qualifications

• Experience in a regulated industry.
• Knowledge of ISO 14644-1; ISO 13485 and ISO 9001 standards.
• Ability to conduct internal audits and lead auditor certification.
• Track record in continuous improvement and lean methodologies.
• Problem-solving skills, including root cause analysis and CAPA management.
• Effective communication and organizational skills.
• Ability to manage change in dynamic environments.

Skills

• Quality assurance and management.
• Product and process validation methodologies.
• ISO standards compliance.
• Internal and external audit coordination.
• Continuous improvement and lean methodologies.
• Root cause analysis and CAPA management.
• Effective communication and stakeholder engagement.

Benefits

• Robust Retirement Plan: 5% employer match on up to 3% of contributions.
• Comprehensive and Supportive Parental Leave: 16 weeks at 100% pay, with a gradual transition to 80% work schedule for the first 6 months.
• Generous Time Off: Up to 15 caregiver days, 9 observed holidays, 80 hours of annual sick leave.
• Community Engagement Opportunities: 3 paid volunteer days each year.
• Additional Benefits: Healthcare plans with HSA contributions, among others.

Pay

$85,000 - $107,000 per year.

Schedule

Full-time.