Quality Supervisor

Responsibilities and Duties:

  • Create and revise Inspection Planning Sheets (IPS) for purchased, manufactured, and assembled goods
  • Create and revise Inspection Records (IRs) for machining first article inspection
  • Create, control, organize, and maintain quality records
  • Develop process, equipment, and software validation plans (IQ/OQ/PQ) and protocols
  • Ensure the execution of quality plans on the manufacturing and assembly floor
  • Ensure thorough and accurate application of inspection criteria to parts, components, assemblies, and incoming materials
  • Initiate and process Supplier Non-conforming Material Reports (SNMN) and Supplier Corrective Action Requests (SCAR)
  • Manage and control the calibration of machining tools and gauges for the shop floor
  • Manage the receiving inspection process
  • Perform component final inspections prior to shipment to Westlake for assembly
  • Perform investigation activities and support the development and implementation of Corrective and Preventive Actions (CAPA)
  • Perform or support internal audits for quality management standards (ISO9001, ISO13485) and medical device regulations (US FDA 21 CFR 820, Health Canada SOR/98-282), as needed
  • Provide guidance and leadership to the quality inspection team
  • Recognize non-conforming materials, initiate Non-conforming Material Reports NMRs, and appropriately inform Quality Management of such events
  • Report on supplier performance to the purchasing department
  • Support audit activities in specific areas of responsibility
  • Support the execution of verification and validation activities

Qualifications:

  • 2 year associate’s or 4 year bachelor’s degree in a science or engineering related discipline (preferred)
  • Quality system training (ISO9001, ISO13485, 21 CFR 820) preferred
  • Not less than 5 years of experience in a quality or manufacturing environment
  • Supervisory experience and/or documented supervisory training
  • Quality Management Systems such as ISO9001, ISO13485, and 21 CFR 820
  • Measuring and gauging techniques
  • Engineering drawings, prints, and tolerances
  • Understand and use measuring instruments typical of Western’s processes such as mechanical gauging, flow measuring equipment, pressure measuring equipment, torque measuring equipment, optical comparator, vision inspection systems, surface finish measuring equipment
  • Basic computer software (e.g. MS Office).
  • Must demonstrate effective supervisory skills.
  • CMM operation or programming skills preferred.

 

Western offers a competitive salary and benefits package. Qualified candidates may submit a resume (MUST include salary requirements) by email to jobs@westernenterprises.com, by fax at 440-871-1279, by mail or in person at: 33672 Pin Oak Parkway, Avon Lake, OH 44012 or 875 Bassett Road, Westlake, OH 44145.  No phone calls, please. DRUG FREE/EOE