The QualityEngineer is responsible for investigating and resolving quality issues acrossthe organization, with a strong emphasis on root cause analysis and theimplementation of corrective and preventive actions (CAPA). This role workscross-functionally to ensure product and process quality, drive continuousimprovement, and support compliance with internal and external qualitystandards.
Whatyou'll be doing:
- ย Investigate quality issues (customer complaints, internal process failures, non-conformances) by identifying root cause using structured problem-solving methodologies (e.g., 5 Whys, Fishbone, Fault Tree Analysis, 8D).
- Ensure timely and accurate recording of all non-conformance issues into the Integrated Management System and TrackWise.
- Lead and coordinate CAPA activities, ensuring actions are linked directly to identified root causes.
- Facilitate CAPA meetings with cross-functional stakeholders and monitor progress, effectiveness, and timely closure.
- Provide oversight and coaching on root cause determination techniques, ensuring consistent and rigorous application across teams.
- Collaborate with internal departments and external suppliers to resolve quality issues and drive process improvements.
- Develop and implement quality processes and best practices to prevent recurrence of issues.
- Lead and/or contribute to quality improvement initiatives and projects.
- Support audits, supplier assessments, and regulatory compliance activities as needed.
- Perform other related duties as assigned.
ย Whoyou'll be working with:
- Sales Engineers
- Customer Service
- After Sales
- Planning/Purchasing
- Supply Chain and Manufacturing
- Regulatory and Compliance Teams
This iswhat you'll need to be successful in this role:
- Education or work experience equivalent to an engineering degree, with strong background in quality systems and tools.
- ย Demonstrated experience in conducting root cause analysis and implementing effective corrective/preventive actions.
- Strong understanding of CAPA processes, quality standards (ISO 9001, ISO 13485, etc.), and risk management.
- ย Excellent communication and interpersonal skills; able to collaborate with internal teams and external stakeholders.
- ย Experience with quality tools and methodologies (e.g., Six Sigma, 8D, FMEA, SPC).
- ย Proficiency in Microsoft Office and experience with quality management systems such as TrackWise or similar.
- ย Strong organizational and time-management skills.
- ย Experience in supplier quality management, audits, and process mapping preferred.
- Leadership experience or the ability to lead cross-functional teams effectively.