Quality Engineer II - Medical Device | Lead QC & CAPA

Peritia; Charlotte (NC); On-site; USD 75,000 - 95,000; Full time

Job summary

Peritia is partnering with a growing medical device manufacturer to hire a Quality Engineer II. This permanent, direct‑hire role focuses on supporting manufacturing and leading the QC inspection team to ensure quality and regulatory compliance.

You’ll own non-conformance investigations from start to finish and drive CAPAs using structured root‑cause analysis, data trends, and corrective actions. You will collaborate with Operations and Engineering to reduce rework, improve throughput, and

Qualifications

• Bachelor’s degree in engineering or related STEM field or equivalent experience.
• 3–6 years of quality engineering experience in medical device or pharmaceutical manufacturing.
• Hands-on experience supporting manual assembly or production processes.
• Proven NC and CAPA experience with a data-driven root cause approach.
• Working knowledge of FDA QMSR (21 CFR 820), ISO 13485 and ISO 14971.
• Experience with IQ/OQ/PQ, pFMEAs and control plans.
• Strong communication skills across all levels of the organization.

Responsibilities

• Lead the QC inspection team day to day, including priorities and inspection standards.
• Own non-conformance investigations from start to finish with root-cause analysis.
• Lead CAPAs using structured methods and validate fixes with data.
• Drive projects to reduce NCs and rework and improve manufacturing efficiency.
• Trend quality data with Pareto charts and control charts, using normalized data.
• Collaborate with production leadership to improve work instructions and batch records.
• Write and review IQ/OQ/PQ protocols, pFMEAs and control plans.
• Support AQL sampling, incoming inspection, supplier quality and audits.

Skills

Quality engineering

Root cause analysis

CAPA

Data analysis

Education

Bachelor's degree in engineering or related STEM field

Tools

Minitab

SPC

Gage R&R

Capability analysis

Job description

Peritia is partnering with a growing medical device manufacturer to hire a Quality Engineer II. This permanent, direct‑hire role focuses on supporting manufacturing and leading the QC inspection team to ensure quality and regulatory compliance.

You’ll own non-conformance investigations from start to finish and drive CAPAs using structured root‑cause analysis, data trends, and corrective actions. You will collaborate with Operations and Engineering to reduce rework, improve throughput, and