OrthoPediatrics · 3 days ago
Quality Engineer
Warsaw, IN
Full-time
Onsite
Mid LevelOrthoPediatrics is an orthopedic company focused on advancing pediatric orthopedics. The Quality Engineer will develop and implement improvements to product quality and quality systems, support New Product Development teams, and conduct supplier audits to ensure compliance with quality standards.
BiotechnologyHealth CareMedicalMedical Device
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
Qualification
Required
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. 21CFR820, ISO 13485, ISO 14971)
Requires a Bachelor degree in Industrial Engineering, Industrial Technology, Mechanical Engineering, Engineering Technology or related field
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
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
Preferred
ASQ certification preferred
Company
OrthoPediatrics
OrthoPediactrics is a medical device company that develops and manufactures orthopedic implants for pediatric orthopedic surgeons.
Founded in 2006
201-500 employees
H1B Sponsorship
OrthoPediatrics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
Funding
Current Stage
Public CompanyTotal Funding
$331.45MKey Investors
BraidwellMidCap Financial
2024-08-05Post Ipo Debt· $75M
2024-01-08Post Ipo Debt· $80M
2022-08-10Post Ipo Equity· $125M
Leadership Team
Dave Bailey
President and CEO
Mark Throdahl
President & CEO
Recent News
2025-11-15
Company data provided by crunchbase