Job Description

Description

 Job Summary

The Quality Engineer is responsible for ensuring that materials, processes, and products meet or exceed UMC’s and customer quality standards while employing the use of continuous improvement methodology.

Key Roles and Responsibilities

The primary duties and responsibilities of the Quality Engineer consist of, but are not limited to:

Quality Management System (QMS) 

• Assist maintaining the QMS in accordance with AS9100 and ISO 13485 standards.
• Support the documentation control system to maintain accurate records and ensure accessibility.
• Establish quality procedures, and processes to maintain product quality and customer satisfaction.

Customer and Supplier Quality 

• Interface with customer and supplier technical representatives to understand quality expectations and address quality concerns.
• Collaborate with Supply Chain, Manufacturing, and other departments to review supplier performance, address quality issues and implement improvement plans.
• Support Supplier and Customer audits, as assigned.

Continuous Improvement

• Implement quality control measures to identify defects, non-conformities, and areas for improvement aimed at improving
  product quality, reliability, and resources to support company goals, objectives, and profitability.
• Support and own Corrective or Preventative actions to address product and/or process conformity.

Part Inspection Process Development and Maintenance

• · Provide quality support to manufacturing at UMC in compliance with quality regulations of ISO 13485 (Medical), AS9100 (Aerospace), and FDA CFR 820 (contract manufacturer). 
• · Utilize customer prints and specifications to create, review, and approve part process inputs and outputs to satisfy internal and external part & process validation requirements.
• · Write and execute equipment validation process for automated inspection equipment (CMM, vision system, etc.) as assigned.

Quality Assurance and Control

•  Review and maintenance of SPC data collection, and statistical analysis.
• Serve as the primary quality resource for problem identification, resolution, loss reporting and continuous improvement.
• Analyze failures in response to customer complaints and customer returns, managing the Return Material Authorization (RMA) activities.
• Monitor and evaluate product quality through inspections, audits, and testing protocols.
• Partner with engineering, manufacturing, and other departments to resolve quality issues, identified through inspections, audits, testing protocols, or other.
• Provide technical and analytical troubleshooting input regarding quality related matters.

General

• Other duties as assigned.

Requirements

Education and Experience

• Undergraduate degree in Engineering or similar technical field or work experience in place of education.
• 3+ years experience in manufacturing with an emphasis on Inspection & Quality.
• Working knowledge of Regulatory requirements including standards within, ISO 9001, ISO 13485, AS9100, RoHS, REACH & ITAR.
• AQS and/or CQE Certification preferred.
• Experienced in Measurement System Analysis, & Statistical Process Control.
• Understanding of best practices methods in inspection, calibration, and automated inspection programming.

Competencies

• · Ability to read blueprints with an understanding of GD&T
• Ability to express ideas, share information, listen actively, and demonstrate      professionalism in written and verbal communications
• Adheres to UMC Quality Standards
• Ensure all internal and external customers receive positive service experiences 
• Promotes a sense of urgency to expedite work though area
• Excellent attention to detail and problem solving skills
• Able to make effective and timely decisions 
• Able to work efficiently with minimal supervision
• Able to work both independently and as a team
• Proficient in various computer software applications such as Microsoft Word, Excel,      and Outlook
• Strong mechanical aptitude
• Embodies the personal commitment to the shared core values of UMC: Great People, Going Beyond, and Growing

Physical Requirements 

• Prolonged periods of sitting at a desk and working on a computer.
• Dexterity with computers - the ability to type and use a mouse. 
• Occasionally lift and/or move up to 20 pounds. 
• Must be able to meet customer demand requirements for performing visual inspection and/or other product acceptance activities    with or without accommodation (only for positions in which this is a requirement of the job per the customer requirement).
• Ability to pass an annual vision test.