Quality Engineer

My client has asked us to assist in identifying a Quality Engineer for a full time opening within their organization.

The Quality Engineer is responsible for supporting and improving the organization’s Quality Management System (QMS) to ensure compliance with ISO standards, customer requirements, and internal manufacturing processes. This role leads internal and external audit activities, drives corrective and preventive actions, supports customer complaint resolution, and promotes continuous improvement initiatives throughout the facility.

• Complete required yearly internal ISO audits per the ISO internal audit schedule.
• Lead the external ISO audits to ensure facility conformance to all ISO specifications.
• Champion all external and internal ISO audit non-conformance to ensure timely closure, process implementation, root cause and corrective actions, mitigation and communicated changes to quality systems manager – lead auditor.
• Champion all customer complaints to ensure root cause and corrective actions have been addressed within 30 days, review all manufacturing processes to ensure mitigation of the non-conformance, re‑audit the process within 90 days for conformance.
• Review and investigate customer complaints for part non-conformance, containment, and quality process documentation updates.
• Champion customer complaint resolution to ensure root cause and corrective actions are addressed and non-conformance is mitigated within the department.
• Review and track Document Change Notices that affect the manufacturing facility, which include part review, containment of part and disposition of part.
• Champion Material Review Board with component and part disposition for non-conformances within the facility.
• Inspection of components and parts for manufactured, purchased and outside processing to ensure all design and customer specifications.
• Inspection of components and parts with micrometers, calipers, comparators, gages (pin and ring) and other quality inspection tools.
• Lead and suggest continuous improvement activities to ensure the quality department is working efficiently to achieve manufacturing and customer requirements for component and part specifications (scrap reduction, non-conformance mitigation internally and externally).
• Create and update quality documentation (process sheets, work instructions, quality alerts, etc.) to standardize process improvements to ensure world-class quality system.
• Complete required review of quality process documents to ensure that documents are up-to-date, relevant to the current processes and conforms to ISO standards.
• Review and address prototype manufacturing concerns to address design and manufacturing non-conformances to help mitigate quality non-conformances.
• Monitor all gages, fixtures and devices for maintenance and calibration requirements per the established calibration process and ISO specifications.
• Complete non-conforming documentation and follow-up to ensure non-conformance is mitigated.
• Complete and/or review all required quality process documents for first‑article inspection, PPAP requirements and supplier review.
• Recommend new test equipment for component and part inspection to improve quality and department efficiency.
• Provide Contract Review support ensuring compliance as part of the Contract Review process.

• Bachelor’s Degree, preferably technically related to Quality such as Statistics or Engineering, or equivalent from an accredited technical institution or related years of experience in a manufacturing quality department.
• Strong experience in Quality Assurance or Control.
• Experience working in a manufacturing environment.
• Working familiarity and understanding of ISO 9001 (ISO 13485 is a plus).
• Working knowledge of drawings and industry standards.