Quality Engineer

Quality Engineer

Founded in 2006, Ortho Pediatrics is an orthopedic company focused exclusively on advancing the field of pediatric orthopedics. As such it has developed the most comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. Ortho Pediatrics currently markets 53 products that serve three of the largest categories within the pediatric orthopedic market. This product offering spans trauma and deformity, scoliosis, and sports medicine/other procedures.

Ortho Pediatrics' global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and over 70 countries outside the United States.

General

Summary:

The Quality Engineer develops and implements improvements to product quality and quality systems and supports New Product Development teams, as well as maintenance on legacy systems. Works with cross-functional teams to determine high-quality manufacturing partners, and conduct supplier audits.

Essential Functions:

• 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.

Supervisory Responsibilities:

There are no supervisor responsibilities with this position.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. (The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)

• Ability to work in a strong team environment.

• Be an expert on new products and company information.

• Proficient in the use of statistical applications; must be familiar with the use of SPC.

• Knowledge on non-destructive testing and measuring techniques.

• Must have excellent verbal and written communications skills.

• Must be analytical and can interpret data.

• Must be familiar with the use of designed experiments.

• Ability to solve problems.

• Strong working knowledge of medical device quality system regulations and standards (e.g. 21

CFR
820, ISO 13485, ISO 14971)

Education and/or

Experience:

Requires a Bachelor degree in Industrial Engineering, Industrial Technology, Mechanical Engineering, Engineering Technology or related field. ASQ certification preferred. Must have computer skills; (MS-Excel). Knowledgeable in gauging methods and their applications.

Language

Skills:

Ability to read and comprehend instructions, correspondence, and memos. Ability to prepare routine reports and correspondence. Ability to communicate effectively with customers, vendors and other employees of the organization. Requires excellent grammar and spelling.

Mathematical

Skills:

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.

Reasoning Ability:
Ability to carry out instructions furnished in written, oral, or diagram form. Ability to use critical thinking to deal with problems involving multiple variables in a variety of situations.

Certificates, Licenses, Registrations:
Requires a valid driver's license.

Other

Skills and Abilities:

Requires the ability to operate a variety of standard office equipment, such as a computer and keyboard, calculator, fax, photocopier, telephone, cell phone, etc. Requires proficiency with Microsoft Word, Excel, Outlook and PowerPoint.

Physical Demands: (The physical demands described here are…