Senior Quality Engineer

Client Details

This is an innovative, global manufacturing organization known for operating in highly regulated industries and delivering critical solutions worldwide. Backed by a publicly traded parent company, they offer strong career development, cutting-edge facilities, and a collaborative culture focused on continuous improvement.

Description

• Lead validation, qualification, and risk management activities across products and processes
• Support New Product Introduction (NPI) with strong quality oversight and compliance guidance
• Develop and maintain QMS processes, including procedures, templates, and documentation
• Partner with engineering, manufacturing, supply chain, and R&D to drive quality initiatives
• Oversee verification & validation (V&V) lifecycle for new and existing products
• Investigate nonconformances, deviations, and complaints using structured RCA methodologies
• Drive CAPA effectiveness using tools such as 5 Whys, Fishbone, and FMEA
• Ensure all product and process changes are risk-assessed and compliant with standards
• Contribute to internal audit programs and support audit readiness
• Train and coach teams on quality systems, validation, and best practices
• Promote a culture of continuous improvement and risk-based thinking

Profile

• Bachelor's degree in Engineering or a scientific discipline
• 5+ years of Quality Assurance experience in a regulated industry
• Strong knowledge of ISO 13485 and ISO 9001 standards
• Hands-on experience with validation methodologies and V&V processes
• Solid understanding of design and development lifecycle (NPI-focused)
• Proven track record in CAPA, root cause analysis, and continuous improvement
• Experience conducting internal audits (Lead Auditor certification a plus)
• Strong cross-functional communication and stakeholder management skills
• Ability to thrive in a fast-paced, evolving manufacturing environment

Job Offer

• Competitive salary ranging from $95000 to $118000 USD annually
• Join a brand-new, advanced manufacturing facility with strong investment
• Play a key role in shaping quality and validation frameworks
• High visibility partnering across engineering, ops, and leadership
• Strong benefits package including generous PTO and parental leave
• Work within a global organization known for stability and growth

Desired Skills and Experience

• Lead validation, qualification, and risk management activities across products and processes
• Support New Product Introduction (NPI) with strong quality oversight and compliance guidance
• Develop and maintain QMS processes, including procedures, templates, and documentation
• Partner with engineering, manufacturing, supply chain, and R&D to drive quality initiatives
• Oversee verification & validation (V&V) lifecycle for new and existing products
• Investigate nonconformances, deviations, and complaints using structured RCA methodologies
• Drive CAPA effectiveness using tools such as 5 Whys, Fishbone, and FMEA
• Ensure all product and process changes are risk-assessed and compliant with standards
• Contribute to internal audit programs and support audit readiness
• Train and coach teams on quality systems, validation, and best practices
• Promote a culture of continuous improvement and risk-based thinking