Supplier 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. For more information, please visit

The Supplier Quality Engineer develops and implements improvements to product quality and quality systems at all currently approved and newly identified suppliers. Works with cross-functional teams to determine high-quality manufacturing partners and conduct supplier audits.

• Define and manage all supplier quality activities.
• Develop, implement, and monitor adherence to supplier product quality requirements.
• Generate and monitor supplier quality metrics.
• Manage supplier CAPA, non-conformances, deviations, and requested changes.
• Conduct supplier and internal quality system audits according to established schedules and quality standards.
• Manage the quality approval of new suppliers.
• Understanding of contracts and legal documents.
• Ability to interface with external auditors.

There are no supervisor responsibilities with this position.

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.
• 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 technical writing skills.
• Must be analytical and can interpret data.
• Ability to solve problems.
• Strong working knowledge of medical device quality system regulations and standards (e.g. 21
  
  CFR
  820, ISO 13485, ISO 14971)
• 5 years of Medical Device Quality experience preferred.

Requires a bachelor’s degree in an Engineering discipline, or equivalent experience in a related quality role. ASQ certification preferred. Must have computer skills; (MS-Excel). Knowledgeable in gauging methods and their applications.

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.

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

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.

Requires a valid driver’s license. ISO 13485 Audit Certification

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,…