The Senior Quality Engineer in will perform corrective action investigations for customer, supplier, and internal, corrective action reports. Through regular contact with internal process owners, suppliers, sister sites, and customers the Senior Quality Engineer will maintain open communication to adequately monitor the status of these corrective actions and ensure they are implemented effectively and in a timely manner. Knowledge of product, processes, and fundamental quality principles are required to assist with assembly problem solving, APQP and other new product development initiatives. The incumbent must also understand the technical aspects of our pneumatic, mechanical, and electronic product lines and manufacturing processes, as well as suppliers’ products and processes, to drive quality improvements and communicate them clearly to management and our customers.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Assist in the management of the quality management system. This includes quality system requirements including test and inspection plans and product reliability, supplier quality program, risk management and to ensure compliance to ISO 9001:2015.
Monitor organizational quality performance and issue corrective action reports as appropriate. Communicate interdepartmentally and with customers to follow up on the status of any corrective action and to ensure its effectiveness, timely response, and closure.
Work in conjunction with manufacturing, engineering, and other departments and sister sites to investigate root cause and develop robust corrective action plans for customer complaints and internal audit findings.
Perform corrective action investigations and write evaluation and 8D corrective action reports on customer rejected product. Maintain communication with the customer contact on the status of any concern and accompanying action items.
Serve on teams as the Quality representative for APQP, new product development, and Engineering Advantage activities. This includes assisting in Potential Failure Mode & Effects Analysis (FMEA), reviewing supplier quality plans, developing inspection plans and verification/validation requirements, and evaluating required prototype and pre-production runs for new/redesigned products and processes.
Provide support to manufacturing, machining, and other production areas regarding product quality, assistance in problem solving/troubleshooting test failure investigations, inspection, and disposition of non-conforming product. Work in conjunction with inspection and Supply Chain to assist in the disposition of rejected supplier product through participation in MRB (material review board) discussions. Recommend to manufacturing/engineering the corrective measures necessary to prevent recurrence.
Support other members of the Quality Department on matters pertaining to inspection, calibration, customer complaints, nonconforming product, and metrics performance. Provide training to other members of the Quality or Manufacturing departments on inspection procedures and techniques, as well as the supervision and/or assignment of other activities which include testing and evaluation.
Assist with preventive action, kaizen events, and continual improvement initiatives.
Prioritize customer requirements and manage internal resources in order to maximize customer satisfaction.
Audit products and processes based on various specifications and standards. Apply detail oriented, technical, critical, methodical behaviors in assessing conformance of product and process to defined requirements. Clearly communicate using written and verbal English the results of investigations and assessments.
Participate in quality departmental meetings regarding associated metrics reporting and support of Lean Manufacturing initiatives.
Maintain on-going industry knowledge, and seek to receive and provide training per the Quality department training matrix such that the department remains sufficiently cross-trained.
Other duties as assigned.
Education and Experience
Bachelor’s Degree in technical discipline, CQE certificate, or have demonstrated equivalent expertise through manufacturing experience.
Knowledge of ISO 9001 and ISO/TS 16949 requirements and proficiency with other industry standard quality techniques such as root cause analysis, 8D reporting, and the AIAG core tools including but not limited to PPAP, MSA, and APQP requirements.
Minimum of 7+ years of experience in a manufacturing environment
Computers and Technology
Proficiency using MS Office Suite (Word, Excel, Access, PowerPoint and Outlook)
Software products such as Minitab
Ability to use them effectively for report generation.
CQE certification through ASQ a plus.
Experience in ISO 13485 and TS 16949