The Medical Device Quality Engineer – Process Validation & Computer System Validation (CSV) role at Skillfi is responsible for ensuring that manufacturing processes and computerized systems meet stringent regulatory and quality standards. This position will lead validation activities, drive continuous improvement, and support compliance across the product lifecycle.

Key Responsibilities

• Plan, execute, and document Process Validation protocols (IQ, OQ, PQ, DQ, TMV) for medical device manufacturing lines.
• Develop, implement, and maintain Computer System Validation (CSV) strategies in accordance with FDA 21 CFR Part 11, EU MDR, and ISO 13485.
• Conduct risk assessments, root cause analyses, and CAPA investigations related to process and system deviations.
• Manage non‑conformance reports (NCRs) and ensure timely corrective actions to maintain GxP compliance and data integrity.
• Collaborate with cross‑functional teams (R&D, Production, Regulatory, IT) to integrate validation requirements into product design and release.
• Maintain and update validation master plans, validation master files, and related documentation to support audits and inspections.
• Provide training and mentorship on validation best practices, GxP principles, and data integrity to internal stakeholders.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or related field; advanced degree preferred.
• Minimum 4 years of experience in Medical Device Quality Engineering with a focus on process validation.
• At least 3 years of hands‑on experience executing IQ, OQ, PQ, DQ, and TMV protocols.
• Proven expertise in Computer System Validation (CSV) and familiarity with GxP, FDA 21 CFR Part 11, and ISO 13485 requirements.
• Strong background (2+ years) in GxP compliance, data integrity, CAPA management, and NCR handling.
• Demonstrated ability in risk management, root cause analysis, and effective communication with regulatory bodies.

What We Offer

• Competitive salary package with performance‑based incentives.
• Comprehensive health, dental, and vision benefits, plus retirement savings plans.
• Professional development opportunities, including certifications and continuous learning programs.
• Collaborative, inclusive workplace culture with flexible work arrangements.