Senior Validation Engineer, Medical Devices & QA

Katalyst-Healthcares-; Warwick (RI); On-site; USD 90,000 - 130,000; Full time

Job summary

Creative Solutions Services, LLC seeks an experienced Validation Engineer to lead IQ/OQ/PQ validation activities in a regulated medical device environment. You will craft validation plans, execute protocols, and ensure documentation meets GMP/GDP and QMS requirements.

You will collaborate with Quality, Engineering, Manufacturing, and R&D to drive CAPA investigations, root-cause analyses, and process improvements, while preparing for FDA inspections and audits.

Qualifications

• Bachelor's degree in engineering or related technical field.
• 3–5 years of validation experience in a regulated industry, preferably medical devices.
• Hands-on IQ/OQ/PQ and process/equipment validation experience.
• 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.

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, and company quality procedures.
• Maintain accurate and complete validation documentation in accordance with GMP/GDP and QMS requirements.

Skills

IQ/OQ/PQ validation

V&V (verification & validation)

CAPA & RCA

Process improvement

Statistical analysis

Minitab

Cross-functional collaboration

Education

Bachelor's degree in engineering, science, or related technical field

Tools

Minitab

Job description

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.