Supplier Quality Engineer — MedTech Quality & Compliance

Orthopediatrics; Warsaw (IN); On-site; USD 80,000 - 110,000; Full time

Job summary

OrthoPediatrics is seeking a Supplier Quality Engineer to lead quality activities with current and new suppliers, driving adherence to quality requirements and metrics. You will coordinate supplier audits and CAPA actions in a structured medical device environment.

Ideal candidates have 5+ years of medical device quality experience, a Bachelor’s in Engineering, and familiarity with 21 CFR 820 / ISO 13485. Proficiency with MS Office is required and travel as needed.

Qualifications

• Bachelor’s degree in Engineering or equivalent quality role experience.
• ASQ certification preferred.
• Proficient with MS-Office; knowledge of gauging methods.

Responsibilities

• Define and manage all supplier quality activities.
• Develop, implement, and monitor supplier quality requirements.
• Generate and monitor supplier quality metrics.
• Manage supplier CAPA, non-conformances, deviations, and changes.
• Conduct supplier and internal quality system audits.
• Manage the quality approval of new suppliers.
• Understand contracts and legal documents.
• Interface with external auditors.

Skills

Team collaboration

Statistical tools (SPC)

Non-destructive testing

Verbal & technical writing

Data analysis

Problem solving

Medical device quality systems (21 CFR

Education

Bachelor’s degree in Engineering

ASQ certification preferred

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

PowerPoint

Job description

OrthoPediatrics is seeking a Supplier Quality Engineer to lead quality activities with current and new suppliers, driving adherence to quality requirements and metrics. You will coordinate supplier audits and CAPA actions in a structured medical device environment.

Ideal candidates have 5+ years of medical device quality experience, a Bachelor’s in Engineering, and familiarity with 21 CFR 820 / ISO 13485. Proficiency with MS Office is required and travel as needed.