Quality Engineer - Medical Device, CAPA & Validation

Medix™; Maryland; On-site; USD 85,000 - 115,000; Full time

Job summary

Medix™ is seeking a Quality Engineer to develop, implement, and improve quality policies and systems in line with ISO 13485, 21 CFR Part 820, GMP and GDP. You will lead CAPA activities from investigation through effectiveness verification and drive cross‑functional problem solving.

You will apply statistical tools, participate in audits, support product development and manufacturing transfer, and mentor the quality team while maintaining documentation and site KPIs.

Qualifications

• Bachelor's degree in Engineering, Science, or related discipline.
• 3–4+ years of Quality Engineering experience in regulated manufacturing.
• Hands-on CAPA management from investigation through implementation and effectiveness checks.
• Experience with IQ/OQ/PQ protocols.
• Knowledge of ISO 13485, 21 CFR Part 820, GMP, GDP.
• Experience with root cause analysis and structured problem-solving.
• Strong analytical and organizational skills and ability to multitask.

Responsibilities

• Develop, implement, and improve quality policies, procedures, and systems in accordance with ISO 13485, applicable GMP/GDP requirements, and 21 CFR Part 820.
• Lead and manage CAPA activities from initiation through effectiveness verification.
• Facilitate structured root cause investigations and drive cross-functional corrective and preventive actions.
• Develop, review, and execute validation strategies/protocols for equipment, processes, software, and test methods (IQ/OQ/PQ).
• Apply statistical tools to identify trends, assess process capability, and monitor quality performance.
• Apply risk management, FMEA, SPC to identify and mitigate manufacturing/product risks.
• Support new product development, design transfer, process development, and manufacturing transfer from a quality perspective.
• Partner with Manufacturing and Engineering to optimize processes and reduce defects.
• Develop and monitor quality metrics and site KPIs; participate in internal, supplier, and regulatory audits.
• Provide quality input into nonconformances, deviations, complaints, change controls, and QA processes.
• Support Management Review through data analysis, reporting, and presentation of performance.
• Develop and deliver training on quality systems and regulatory requirements, mentoring others.

Skills

CAPA management

Root cause analysis

IQ/OQ/PQ protocols

ISO 13485 knowledge

21 CFR Part 820 knowledge

GMP/GDP knowledge

Data analysis

Cross-functional collaboration

Quality systems documentation

Multitasking

Education

Bachelor's degree in Engineering, Science, or related technical discipline

Job description

Medix™ is seeking a Quality Engineer to develop, implement, and improve quality policies and systems in line with ISO 13485, 21 CFR Part 820, GMP and GDP. You will lead CAPA activities from investigation through effectiveness verification and drive cross‑functional problem solving.

You will apply statistical tools, participate in audits, support product development and manufacturing transfer, and mentor the quality team while maintaining documentation and site KPIs.