Quality Engineer
About the Company
OrthoPediatrics is an orthopedic company focused exclusively on advancing the field of pediatric orthopedics. The company has developed the most comprehensive product offering to the pediatric orthopedic market, currently marketing 53 products that serve three of the largest categories within the pediatric orthopedic market: trauma and deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics' global sales organization distributes its products in the United States and over 70 countries outside the United States.
About the Role
The Quality Engineer develops and implements improvements to product quality and quality systems, supports New Product Development teams, and maintains legacy systems. This role works with cross-functional teams to determine high-quality manufacturing partners and conduct supplier audits.
Responsibilities
- Develop, implement, and monitor adherence to product quality plans
- Develop product documents to establish form, fit and function information which can be used as a basis for making quality decisions
- Provide quality costing information and analysis to monitor quality and identify unfavorable trends
- Identify approved gauging and measurement techniques
- Specify measurement equipment and improve gauging methods
- Ensure compliance with internal and customer imposed quality standards
- Reduce cost by eliminating or reducing non-conforming materials and/or products
- Diagnose and assist in the resolution of quality problems and implement programs to improve product quality
- Conduct supplier and internal quality system audits according to established schedules and quality standards
Qualifications
- Ability to work in a strong team environment
- Expert on new products and company information
- Proficient in the use of statistical applications; familiar with the use of SPC
- Knowledge of non-destructive testing and measuring techniques
- Excellent verbal and written communications skills
- Analytical with ability to interpret data
- Familiar with the use of designed experiments
- Ability to solve problems
- Strong working knowledge of medical device quality system regulations and standards (e.g. 21CFR820, ISO 13485, ISO 14971)
Education and Experience
- Bachelor degree in Industrial Engineering, Industrial Technology, Mechanical Engineering, Engineering Technology or related field
- ASQ certification preferred
- Computer skills (MS-Excel)
- Knowledgeable in gauging methods and their applications