SSE Academy
Senior Quality Engineer - WMA
Devens, MA, US · Senior
Sponsorship not specifiedDetected 96 days ago
ComplianceProduct ManagementAuditingSupply ChainMedical DevicesCommunicationProblem SolvingMentoringInternal Audit
About the role
- 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.
- What you'll be doing As a Senior Quality Engineer, you will be performing a vital and varied role that includes the following: Strong background in managing sterility control and compliance programs.
- Work closely with the validation technical SME to ensure effective verification and validation (V V) of new products and processes within the NPI lifecycle.
Responsibilities
- Develop, implement, and sustain effective quality management system (QMS) processes, including the creation and control of procedures, templates, and quality records.
- 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.
- In-depth understanding of the design and development lifecycle.
- Proficient in conducting internal audits; lead auditor certification is highly desirable.
- Excellent communication, planning, and organisational skills Resilient and delivery-focused, with a strong ability to manage change in dynamic environments
Requirements
- This is what you'll need to be successful in this role Bachelor's degree in engineering, or a scientific discipline.
Company info
- 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.
- Visit our website to learn more.
- Role Summary The Senior Quality Engineer is responsible for leading, developing, and maintaining the product's quality validation, product qualification, and risk management programs, ensuring alignment with ISO standards, internal Quality Management Systems, and regulatory expectations.
- This role supports NPI (New Product Introduction) and Design Development Quality, providing technical oversight and quality governance on all activities including production to ensure product safety, regulatory compliance, and robust validation lifecycle control.
- Acting as the product's subject matter expert (SME) in quality validation, risk management, and metrology, the Senior Quality Engineer collaborates with cross-functional stakeholders in Engineering, Manufacturing, R D, Supply Chain, and Quality Assurance to drive consistent, compliant, and effective practices.
- 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.
- Be part of the internal audit team, conducting and generating audit reports to drive process improvements.
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