Quality Engineer

Reports to: VP of Engineering

Job Purpose

The Quality Engineer is responsible for implementation of process and product changes that yield improvements in product quality, efficiency, cost reduction, and plant sustainability.

Key Job Functions/Duties

Implement applicable Quality Management systems plans and procedures to ensure compliance to internal ISO requirements
Asist in the implementation of ISO 13485:2016 medical devices into the medical quality system
Expand receiving and inspection process
Lead and assist in root cause analysis and facilitate the corrective/preventative action of Quality issues

Perform data analysis and provide charts and reports to promote continuous improvement and create a proactive team environment through coaching and motivational techniques.
Participate in NPD using risk analysis tools to eliminate design, manufacturing, and customer issues from occurring.
Review non-conforming material, disposition, implement corrective and preventative actions, and communicate with suppliers and Quality Manager regarding action and improvement.
Maintain and communicate information on customer returns including warranty analysis and dispositions.
Administer and update Quality information system activities for CAR’s, calibration, and document control.
Provide training to Quality Technicians, Team Leads and Operators in regarding established quality processes.
Travel to customers to review product quality issues, troubleshoot, and implement fixes.

Knowledge, Skills, & Experience Required

A bachelor’s degree in an Engineering discipline is required, as is 4-8 years of experience in Manufacturing Environment working with quality/process improvement. Medical equipment experience is desired
Ability to understand controls and mechanical designs is desired.
Excellent written and verbal communication skills and the ability to work well with people at all levels are essential. Must have strong organizational, analytical, problem-solving skills.
Experience with ISO 9001:2015/13485:2016 and other related business standards.
Experience with 8D methodology, Control Plans and PFMEA desired.
Candidate must have ability to effectively handle multiple projects simultaneously.
Ability to work with minimal supervision and possess a willingness to make autonomous decisions.
Six Sigma Lean GB certification is desired.
Ability to create and drive change and effectively communicate throughout the organization.
Ability to achieve goals through influencing others.
Works with integrity and respect displaying a high degree of tact and diplomacy.
Must be familiar with various measuring devices and analyzing information
Willingness to travel up to 10 – 15%

Travel Requirements

10-15%

Location

Harrison, Ohio

Work Conditions

While performing the duties of this job in the Plant or Warehouse, the employee can be exposed to noise. The noise level is usually moderate but hearing protection may be required in designated areas.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is occasionally required to stand, walk, and sit. The employee will use hands to handle or feel objects, tools, or controls, reach with hands and arms, climb stairs, balance, stoop, kneel, crouch or crawl, talk or hear. The employee is frequently required to sit and to use a computer keyboard with mouse for long periods of time. The employee will occasionally lift and/or move 25 pounds.

Company

Powerex has become a leader in vacuum and air systems through our foundation built on engineering, innovation, quality, and service. We are a highly integrated operation where we not only assemble systems, but we also manufacture many of the major components. We are committed to providing the best value in the market we serve by applying these pillars of our foundation in every system we build.

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