Quality Engineer

Found in: Appcast US C2 - 2 weeks ago

Northborough, United States Trelleborg Sealing Solutions Full time

Responsible for the development and administration of a Quality System compliant to FDA and ISO requirements, including the utilization of optimal, cost-effective lean manufacturing processes and methods for new and existing projects including inspection, test and label control operations. Working with internal and external customers supports, quality and continuous improvement using appropriate tools, project leadership.


Quality Engineer Expectations:

  • Supports internal audit program as necessary.
  • Supports customer complaint (CC) and RMA system per procedures. Performs investigations, supports determination of the disposition of returned goods, determines re-inspection requirements, determines corrective and preventive actions (CAPA), issues complaint reports, supports completion of customer CAPAs, and approves to close. Looks for trends to determine actions to decrease number of CCs
  • Maintains Non-Conforming (NC) system per procedures. Performs investigations, participates in MRB (Material Review Board) activities, supports determination of the disposition, determines re-inspection requirement, supports determination of corrections/corrective actions and approves to close. Looks for trends to decrease number of NCs and provide feedback to management
  • Maintains corrective and preventive action (CAPA) system per procedures. Initiates and performs root cause analysis. Uses statistical and capability analysis to solve problems. Implements and verifies CAPAs
  • Performs trend analysis of CAPA, NCM, Complaint/Customer Feedback, Risk Management activities, Audits, etc. and presents periodic reports for management review. Assesses Design and any associated activities for manufacturability.
  • Adheres to the company’s Quality System (QS), writes and approves QS documents
  • Authors and executes Quality Plans for Quality Management Systems and Organizational Objectives projects.
  • Support Engineering, Manufacturing, and Inspection personnel in design, methods, tooling, validations, and other areas related to the control of product quality.
  • Communicates with customers on complaints, process changes, clarification of specifications, completing customer documents, and other projects as needed
  • Conducts studies including Gauge R&R’s to develop inspection methods and test equipment. Creates measurement system programs, when necessary.
  • Establishes inspections and sampling procedures to ensure the control of quality at the most economical costs
  • Creates, reviews and approves Equipment Qualifications, Process, Cleaning, and Software Validation, pFMEA and other documentation as necessary.
  • Participates in customer and ISO audits.


Quality Engineer Qualifications:

Required:

  • 4-year degree in quality, engineering, or related field
  • ISO 13485 understanding & experience

Desired:

  • 2+ years in manufacturing environment in a technical support role
  • ASQ Certified Quality Engineer
  • Formal Six Sigma Yellow/Green belt training

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