Senior Quality Engineer

Location: Vandalia, Ohio
Category: Engineering
Employment Type: Direct Hire
Job ID: 558050
Date Added: 05/11/2023

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BelFlex is recruiting a Senior Quality Engineer for a direct hire position.

Position Overview:
Senior Quality Engineer will provide leadership in promoting quality assurance principles throughout the organization. Develop departmental strategy and vision to ensure adherence with customer expectations. Manage all aspects of the Quality Management System to ensure compliance with applicable regulations and standards in support of regulatory and certification requirements such as ISO9001, ISO13485, ISO14001 and QSR 21 CFR 820 (cGMP). Resolve all customer quality issues through definition of the product, advance quality planning, and prompt resolution of rejections. Drive continuous improvement efforts across the organization.

Job Responsibilities:
  • Initiate and implement quality improvement activities to assure process performance, in a cost-efficient manner.
  • Design, implement and document procedures for process control, improvement, testing, validation, and inspection.
  • Monitor the status of customer rejections, and containment. Facilitating resolutions.
  • Utilize 8-D team-oriented problem solving as required.
  • Develop and maintain the “Integrated” Quality & Environmental Manual and company procedures on a continuous basis and communicate any significant changes to all applicable personnel.
  • Oversee and monitor the quality system measurables. Bring unfavorable trends to the attention of Top Management. Report serious issues, not corrected through normal channels, to the President.
  • Establish and monitor quality and basic skills training programs, within budgetary constraints.
  • Assure that the duties and performance of all Quality Assurance personnel (engineers, technicians, inspection, and test personnel) are properly monitored to assure maximum effectiveness and efficiency of those resources.
  • Assure that accurate PPAP and FA submittals to customers are completed on a timely basis.
  • Pursue and accomplish all significant customer certifications and audits required to obtain and/or retain business.
  • Promote advanced quality planning in a cost effective and timely manner with cross-functional team involvement. This includes the development of Control Plans, Process FMEA”s and Process Flow Diagrams.
  • Help to establish guidelines and requirements for certification of suppliers and support Materials Manager in supplier evaluation and supplier performance measurement.
  • Assist in development of new products to meet the needs of customers. Attending customer trials as required.
  • Assist in creation of COC, COA, COO and other test reports as required.
  • Oversee Internal Change Request process, and support customer ECO process for external changes.
  • Oversee company warranty system, including RMAs, rework orders, customer credits, etc.
  • Ensure that company products meet regulatory requirements including allergen and other compliance statements, labeling, SDS and Conflict Mineral requirements, and test protocols. Develop policies as required.
  • Conduct or supervise audits of incoming, in-process and finished goods. Help determine disposition of rejects.
  • Serve as Management Representative for ISO9001, ISO13485, ISO14001 or any other similar standards.
  • Travel as required in support of company quality objectives (typically less than 5%).

  • 4-year college degree or 2-year technical degree and 10 years quality management and/or supervision experience in a manufacturing environment.
  • Proficient in Microsoft EXCEL and PowerPoint.
  • Knowledgeable in use of MRP systems, root cause/corrective actions, Lean, 5-S, continuous improvement, and creation of Control Plans & Process FMEAs.
  • General ability to lead the quality program. Timeliness in meeting stated objectives.
  • Provide Recommendations made to top management as requirements to support and achieve company quality objectives.
  • Knowledge of Continuous Improvement of all applicable quality system measurables.
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