Quality Engineer Job Description:
Quality Engineer duties and responsibilities
Quality Engineers help create solutions as part of an engineering team. They work to find defects, determine the causes of those defects and provide solutions to defected problems. The Quality Engineer has several other duties and responsibilities, some of which include:
The Quality Engineer position works closely with the engineering team and customers to launch new products and processes in a Medical Device manufacturing setting. In addition, this position leads corrective action and continuous improvement activities in collaboration with the company’s quality vision and strategy.
Team member of medical device validation team with Quality Assurance Engineering responsibilities
Ensure validation documentation meets all requirements per GMP standards.
· Coordinates, reviews, and submits First Articles, PPAPs, and sample parts for customer approval.
· Handles internal and external quality issues and drives timely and effective corrective actions.
· Implements, maintains, and audits company quality systems.
· Communicates quality issues to production personnel through work aids.
· Develops control and inspection plans for operations as well as incoming materials and components.
· Communication Proficiency
· Decision Making
· Problem Solving/Analysis
· Results Driven
· Technical Capacity
This position has no supervisory responsibilities.
The Quality Engineer has frequent interaction with other functional roles and departments (e.g. project engineering, automation, tool engineering, and processing). Most work is performed in an office environment, yet this position also will collaborate with production staff in manufacturing areas. While performing the duties of this job, the employee must wear appropriate personal safety protection equipment.
The employee will be required to stand or walk in the production areas and sit at a desk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
Required Education and Experience
Bachelor’s degree in an engineering field
Prior use of measuring tools such as: calipers, micrometers, go/no go gauges, and height and depth gauges
Preferred Education and Experience
1-3 years of experience in a quality role; medical device preferred
ISO13485 regulation understanding and experience (medical devices)
Strong knowledge of statistics
Six Sigma Lean Certification belts a plus
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.