Quality Engineer II - Medical Device

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 is a permanent, direct-hire role focused on supporting manufacturing. You’ll lead the QC inspection team, partner with Operations and Engineering, and help reduce rework and increase throughput in a regulated FDA / ISO 13485 environment.

What You’ll Do

• Lead the QC inspection team day to day, including priorities, workload and inspection standards
• Own non-conformance investigations from start to finish, working with line operators and inspectors to find causes and put effective fixes in place
• Lead CAPAs using structured root cause analysis (5 Whys, fishbone, DMAIC), and use data to confirm the root cause and that the fix worked
• Drive projects that reduce NCs and rework and improve efficiency, such as cutting QC inspection time
• Trend quality data and metrics using Pareto charts, control charts / X-bar R and normalized data
• Partner with production leadership to improve how well the floor follows work instructions and keeps up batch records and GMP documentation
• Write and update Work Instructions and Work Aides with Sustaining Engineering (poka-yoke, 5S)
• Write and review IQ/OQ/PQ protocols, pFMEAs and control plans
• Support AQL sampling, incoming inspection, supplier quality and audits

What You Bring

• Bachelor’s degree in engineering or a 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 approach to root cause
• Working knowledge of FDA QMSR (21 CFR 820), ISO 13485 and ISO 14971
• Experience with process validation (IQ/OQ/PQ), pFMEAs and control plans
• Strong communication skills, with the ability to connect respectfully with everyone from line operators to directors and auditors

Nice to Have

• Experience with both manual and automated manufacturing
• Minitab, SPC, Gage R&R and capability analysis
• Lean / Six Sigma (Green Belt or ASQ CQE a plus)
• Prior lead or supervisory experience with inspectors or technicians
• Experience with sterilization and packaging validation, supplier audits or EU MDR