Quality Engineer

The Quality Engineer is responsible for ensuring that OpTek Systems manufactured and purchased components and parts meet all product quality requirements, defined from blueprints and customer quality requirements. The Quality Engineer is also responsible for the maintenance, enforcement, and daily compliance with OpTek System’s Quality Management System. Completion of these requirements through measurement and visual verification to ensure customer requirements meet or exceed the ISO 9001 Standard.  Essential Functions & Responsibilities:  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 closer, 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 facilityInspection 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.Inspection and review of dummy paperwork and final dummy inspection to ensure all documentation match prior to shipping.Lead and suggest continuous improvement activities to ensure the quality department is working efficiency 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 mitigation 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.Other duties as assignedQuality Inspection Department KPI’s:Overdue Documents, First Time Yield, Department Efficiency, Internal Complaints Critical Competencies / Physical Demands: Critical Competencies:Ability to read and interpret engineered drawings and tolerance specifications.Ability to effectively use inspection measurement equipment, gages, calipers, height gage, micrometers, and other devices.Ability to use hand tools; allen wrenches, wrenches, etc.Physical Demands:Ability to stand and stoop throughout the shift to inspect parts,Ability to lift and carry weights up to 50 pounds throughout the shift.Ability to safely handle materials and chemical solvents if required. Education and/or Experience:  •    Bachelor’s degree, preferably Technically related to Quality such as Statistics or Engineering, or equivalent from accredited technical institution or related years of experience in manufacturing quality department•    2-4 year's experience in Quality Assurance or Control•    1-3 year's experience in a manufacturing environment•    Working familiarity and understanding of ISO 9001 (ISO 13485 is a plus)•    Working knowledge of drawings and industry standards