Quality Engineer

Quality Engineer

Job Juncture | South Killingly, CT, US
Salary Range:$70,000 – $92,000 Salary range estimated by Zippia

Posted 15 days ago

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Summary: Our Client seeks an experienced Quality Engineer to be responsible for driving operational excellence with our Client's group by providing technical and hands-on support for Operations, Secondary Operations and New Product Development. The successful individual will be a leader that works on cross functional initiatives that improves product quality while reducing cost through work process improvements.

Essential Duties & Responsibilities:

  • Maintain the quality system in compliance with ISO 13485 and other relevant international standards and regulations.

  • Understands business priorities, leads, and supports a culture of quality and compliance while communicating and ensuring the team is focused on initiatives that help meet quality objectives and improve effectiveness of the quality system.

  • Build and maintain positive and productive working relationships with all departments and current/potential suppliers while supporting and collaborating with other departments on quality requirements and associated processes.

  • Oversee and lead quality activities including but not limited to:

    • CAPAs, complaints

    • Non-conforming product/process

    • Support internal and external audits; may serve as Lead Auditor for internal audits.

    • Data analysis

    • Document control / Change control

    • Equipment calibration

    • Control of quality records

    • Incoming, in process and final inspections

    • Training program

  • Communicates for the Quality Team to the Extrusion, Filmcast, Assemblies and New Product Development Teams on abilities and constraints when they exist.

  • Establish and/or modify quality processes to improve operational efficiencies and simplicity.

  • Develop and monitor quality metrics and goals and provide data-driven recommendations to senior management.

  • All other responsibilities as assigned by supervisor.

Required Qualifications:

  • Bachelors Degree in Plastics, Mechanical, Chemical or Biomedical Engineering

  • Minimum 5 years experience in a manufacturing environment

  • ASQ Certified Manager of Quality/Organizational Excellence, ASQ Certified Quality Auditor, ASQ Certified Quality Engineer or ASQ Certified Six Sigma Black Belt

  • Working knowledge of ISO 13485:2016

  • Extensive knowledge of REACH, ROHS, Conflict Mineral, Prop 65, Material Declarations

  • Must possess excellent technical and interpersonal skills

  • Must have good written and oral communication skills, self-motivated, and have good organization and project management skills.

  • Must demonstrate initiative, balanced assertiveness, flexibility and teamwork.

  • Skills and ability to interpret Engineering Drawings, Specifications in regards to manufacturing.

  • Working knowledge of GR&R, PFMEA, Cpk, Ppk, IQ/OQ/PQ and SPC.

  • Proficient in the use of Micrometers, Verniers, Vision Systems, Pin Gages, and related precision measuring instruments.

  • Gage calibration systems to include recall/schedules for recalibration.

Preferred Qualifications:

  • Bachelors Degree in Mechanical Engineering, Electrical Engineering, or Chemical Engineering

  • 10 years experience in a medical device company

  • Certified Manager of Quality/Organizational Excellence, ASQ Certified Quality Auditor, ASQ Certified Six Sigma Black Belt

  • Working knowledge of Statistical Process Control (Minitab), Microsoft Office, plastic extrusion, molding or plastic materials science knowledge, or related experience preferred.

Physical Requirements:

  • Position requires data entry and regular use of computer/keyboard/mouse for extended periods of time.

  • The employee must occasionally lift and/or move up to 20 pounds.