Medical Device Validation Engineer (IQ/OQ/PQ)

Katalyst-Healthcares-; Irvine (CA); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

Creative Solutions Services, LLC in Irvine seeks an experienced Validation Engineer to support validation activities, quality systems, and new product development in a regulated medical device environment.

You will lead IQ/OQ/PQ protocols, review plans and reports, and collaborate with Quality, Engineering, Manufacturing, R&D, and Operations to ensure compliance with FDA regulations and ISO 13485/14971. Proactive CAPA and V&V initiatives drive quality improvements.

Qualifications

• 3–5 years of validation experience in a regulated industry.
• Hands-on IQ/OQ/PQ and process/equipment validation.
• Knowledge of FDA medical device regulations, ISO 13485, and ISO 14971.
• Experience with CAPA, root cause analysis, deviations, and process improvement.
• Experience supporting verification and validation activities.

Responsabilités

• Develop, review, and execute IQ, OQ, and PQ validation protocols for processes, equipment, systems, and software.
• Prepare and maintain validation plans, protocols, reports, and supporting documentation.
• Support process validation, equipment qualification, and verification & validation (V&V) activities.
• Review validation documentation and identify compliance gaps, risks, and deficiencies.
• Support CAPA investigations, root cause analysis (RCA), deviations, and corrective actions.
• Identify and implement process improvements to improve quality, reliability, and efficiency.
• Support FDA inspection readiness, audits, and quality system activities.
• Perform statistical analysis of validation and process data using appropriate methods.
• Use Minitab and statistical techniques, including P-value analysis, where applicable.
• Collaborate with Quality, Engineering, Manufacturing, R&D, Operations, and other cross‑functional teams.
• Work with customers and internal stakeholders to manage validation projects, requirements, timelines, and deliverables.
• Ensure validation activities comply with FDA regulations, ISO 13485, ISO 14971, and company quality procedures.
• Maintain accurate and complete validation documentation in accordance with GMP/GDP and QMS requirements.

Connaissances

IQ/OQ/PQ validation

Minitab usage

Statistical analysis

CAPA investigations

RCA

FDA regulations

ISO 13485

Cross-functional collaboration

Formation

Bachelor's degree in engineering

Outils

Minitab

Description du poste

Job summary
We are seeking an experienced Validation Engineer to support validation activities, quality systems, and new product development within a regulated medical device environment. The ideal candidate will have hands-on experience with IQ/OQ/PQ, process andequipment validation, verification and validation (V&V), CAPA, root cause analysis,and process improvement. The candidate will collaborate with cross-functional teams and customers to ensure validation activities meet regulatory, quality, and business requirements.

Roles & Responsibilities:

• Develop, review, and execute IQ, OQ, and PQ validation protocols for processes, equipment, systems, and software.
• Prepare and maintain validation plans, protocols, reports, and supporting documentation.
• Support process validation, equipment qualification, and verification & validation (V&V) activities.
• Review validation documentation and identify compliance gaps, risks, and deficiencies.
• Support CAPA investigations, root cause analysis (RCA), deviations, and corrective actions.
• Identify and implement process improvements to improve quality, reliability, and efficiency.
• Support FDA inspection readiness, audits, and quality system activities.
• Perform statistical analysis of validation and process data using appropriate methods.
• Use Minitab and statistical techniques, including P-value analysis, where applicable.
• Collaborate with Quality, Engineering, Manufacturing, R&D, Operations, and other cross-functional teams.
• Work with customers and internal stakeholders to manage validation projects, requirements, timelines, and deliverables.
• Ensure validation activities comply with FDA regulations, ISO 13485, ISO 14971, and company quality procedures.
• Maintain accurate and complete validation documentation in accordance with GMP/GDP and QMS requirements.

Education & Experience

• Bachelor's degree in engineering, Science, or a related technical discipline.
• Preferred disciplines include Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Chemical Engineering, Manufacturing Engineering, or Life Sciences.
• 3–5 years of validation experience in a regulated industry, preferably medical devices.
• Hands-on experience with IQ/OQ/PQ and process/equipment validation.
• Knowledge of FDA medical device regulations, ISO 13485, and ISO 14971.
• Experience with CAPA, root cause analysis, deviations, and processimprovement.
• Experience supporting verification and validation activities.