Senior Quality Engineer

Senior Quality Engineer

As a Senior Quality Engineer, you will be performing a vital and varied role in managing and training your designated quality team in all aspects of their responsibilities. Interpreting daily requirements from the WMFTS Devens site SLT together with production outputs to accurately allocate staff workload to ensure we meet the needs of our customers.

Key accountabilities include:

• Supervise your designated Quality Team.
• 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 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 global 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 A minimum of 2 years supervising a Quality Assurance team. 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.