SSE Academy
Sales Quality Engineer
Wilmington, MA, US
Sponsorship not specifiedDetected 44 days ago
ComplianceSupply ChainProcess ImprovementCustomer SupportMedical DevicesLeadershipCommunicationProblem SolvingMentoringMicrosoft Office
About the role
- The Quality Engineer is responsible for investigating and resolving quality issues across the organization, with a strong emphasis on root cause analysis and the implementation of corrective and preventive actions (CAPA).
- What you'll be doing: 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.
Responsibilities
- Lead and coordinate CAPA activities, ensuring actions are linked directly to identified root causes.
- 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.
- Excellent communication and interpersonal skills; able to collaborate with internal teams and external stakeholders.
- Leadership experience or the ability to lead cross-functional teams effectively.
- This role works cross-functionally to ensure product and process quality, drive continuous improvement, and support compliance with internal and external quality standards.
Requirements
- Strong understanding of CAPA processes, quality standards (ISO 9001, ISO 13485, etc.), and risk management.
- Experience with quality tools and methodologies (e.g., Six Sigma, 8D, FMEA, SPC).
- Proficiency in Microsoft Office and experience with quality management systems such as TrackWise or similar.
Nice to have
- Experience in supplier quality management, audits, and process mapping preferred.
Benefits
- Education or work experience equivalent to an engineering degree, with strong background in quality systems and tools.
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This listing is sourced directly from SSE Academy's careers page and normalized into a canonical job model.