Reports to: VP of Engineering
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%