Medical Device Supplier Quality Engineer – Audits & CAPA

OrthoPediatrics Corp.; Warsaw (IN); On-site; USD 85,000 - 110,000; Full time

Job summary

OrthoPediatrics Corp. seeks a Supplier Quality Engineer to drive product quality and quality systems across suppliers and to partner with cross-functional teams to select high-quality manufacturing partners and conduct supplier audits.

Responsibilities include defining supplier quality activities, enforcing quality requirements, tracking metrics, managing CAPA and deviations, and guiding supplier approvals while interfacing with external auditors.

Qualifications

• Bachelor’s degree in Engineering or related quality field.
• ASQ certification preferred.
• 5 years of medical device quality experience preferred.
• Proficient with MS Excel and data analysis tools.
• Familiar with ISO 13485, 21 CFR 820, ISO 14971.

Responsibilities

• Define and manage 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.
• Interface with external auditors.

Skills

Teamwork

Statistical analysis

SPC

Data interpretation

Analytical thinking

Education

Bachelor's degree in Engineering

ASQ certification preferred

Tools

MS Excel

MS Word

PowerPoint

MS Outlook

Job description

OrthoPediatrics Corp. seeks a Supplier Quality Engineer to drive product quality and quality systems across suppliers and to partner with cross-functional teams to select high-quality manufacturing partners and conduct supplier audits.

Responsibilities include defining supplier quality activities, enforcing quality requirements, tracking metrics, managing CAPA and deviations, and guiding supplier approvals while interfacing with external auditors.