Senior Supplier Quality Inspector

OrthoPediatrics•Warsaw, IN

6d•Hybrid

About The Position

The Senior Supplier Quality Inspector is responsible for performing advanced product quality inspections directly at Orthopediatrics’ supplier locations. This role serves as an on‑site quality presence, ensuring components and finished medical devices meet all critical‑to‑quality requirements, specifications, and regulatory expectations. The position requires a highly self‑directed individual capable of independently generating inspection documentation, developing inspection methods, and serving as a technical resource for supplier‑related quality activities.

Requirements

Ability to work independently with minimal oversight in supplier environments.
Strong ability to read and interpret product drawings/prints, specifications, and GD&T.
Detailed knowledge of non‑destructive testing, inspection techniques, and metrology equipment (micrometers, calipers, optical comparators, go/no‑go gauges, etc.).
Demonstrated experience developing and maintaining inspection‑related SOPs and Work Instructions.
Excellent verbal and written communication skills, including the ability to communicate effectively with suppliers, internal teams, and cross‑functional stakeholders.
Strong problem‑solving skills and critical thinking abilities.
Working knowledge of medical device quality system regulations, including FDA QMSR, ISO 13485, cGMP, cGDP, and EU MDR.
Ability to maintain accurate documentation and records.
Skilled in identifying and evaluating critical‑to‑quality attributes during inspection.
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 the ability to operate a variety of standard office equipment, such as a computer and keyboard, calculator, fax, photocopier, telephone, cell phone, etc.
Proficiency with Microsoft Word, Excel, Outlook and PowerPoint.

Nice To Haves

Experience performing inspections at supplier sites preferred.
ASQ certification preferred.

Responsibilities

Conduct on‑site inspections at supplier facilities using appropriate gaging, metrology tools, and inspection methods to verify conformance to specifications.
Develop, refine, and document inspection methods, including SOPs, work instructions, and inspection plans tailored to supplier processes and product characteristics.
Independently generate inspection documentation, including inspection records, reports, and supplier feedback summaries (when applicable).
Evaluate supplier‑provided inspection data and verify accuracy, completeness, and alignment with Orthopediatrics’ requirements.
In partnership with development/design engineering, identify critical‑to‑quality characteristics and ensure inspection activities are aligned with risk‑based quality expectations.
Support CAPA activities related to supplier performance, inspection failures, or recurring quality issues.
Assist with MSA and Gauge R&R studies to validate inspection methods and measurement systems used at supplier sites.
Act as a subject matter expert for supplier‑related inspection processes and daily quality operations.
Maintain clean, safe, and organized inspection work areas while working independently at supplier facilities.
Provide training or guidance to supplier personnel or new internal team members as needed.
Support other operational quality activities when not performing supplier‑site inspections