Quality Engineer

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.