Senior Quality Engineer

Company: [Not Specified]

Location: [Not Specified]

About the Role:

The Senior Quality Engineer is responsible for leading, developing, and maintaining the site’s quality validation, product qualification, and risk management programs. This role ensures alignment with ISO standards, internal Quality Management Systems (QMS), and regulatory expectations. You will support New Product Introduction (NPI) 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. As the site’s subject matter expert (SME) in quality validation, risk management, and metrology, you will collaborate with cross-functional stakeholders in Engineering, Manufacturing, R&D, Supply Chain, and Quality Assurance to drive consistent, compliant, and effective practices.

Key Accountabilities:

• Supervise your designated team.
• Develop, implement, and sustain effective QMS processes, including the creation and control of procedures, templates, and quality records.
• Provide quality engineering guidance and support to NPI projects and change management, ensuring all quality deliverables are completed on time and in compliance.
• Collaborate with validation technical SMEs to ensure effective verification and validation (V&V) of new products and processes within the NPI lifecycle.
• Champion thorough investigation of nonconformities using the eQMS Quality Event process (product non-conformances, process deviations, customer complaints).
• Drive effective Corrective and Preventive Actions (CAPA) through structured root cause analysis (e.g., 5 Whys, Fishbone, FMEA).
• Drive improvements in design, product, and process changes by ensuring impact and risk assessments are documented and implemented per quality standards.
• Collaborate with cross-functional teams to implement quality improvements aligned with the WMFTS Quality Strategy.
• Support validation activities by ensuring the development and maintenance of validation protocols, procedures, and documentation.
• Participate in 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.
• Promote a culture of quality, continuous improvement, and risk-based thinking.
• Other duties as assigned.

Skills & Experience:

• 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 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 management.
• Excellent communication, planning, and organizational skills.
• Resilient and delivery-focused, with a strong ability to manage change in dynamic environments.

Benefits:

• [Not Specified]

Company Values:

• [Not Specified]