5-7 years of experience in medical device process validation
Strong knowledge of equipment qualification and quality systems documentation
Proven experience in cross-functional project leadership
Familiarity with regulatory compliance requirements for medical devices
Background in project management preferred
Responsibilities
Lead validation and remediation activities for service center compliance
Develop and execute validation protocols for equipment
Ensure compliance of equipment calibration and maintenance
Review and update necessary validation documents and SOPs
Manage updates related to the approved supplier list and documentation
Oversee engineering change requests and documentation within PLM
Coordinate with various teams to ensure compliance and quality standards
Provide leadership to achieve project timelines and deliverables
Assist in audits preparation and remediation efforts
Travel to service centers in Latin America and Asia for assessments
Benefits
Opportunity to work with a leading medical device manufacturer
Collaborative environment with cross-functional teams
Chance to make a significant impact on global service operations
Professional development through exposure to diverse operational challenges
Possibility for travel, enhancing professional experience in international settings
Full Job Description
Job description:
Our client is seeking a Senior Process Validation Engineer to support a large medical device manufacturer in re-establishing and standardizing global service center operations to ensure audit readiness and regulatory compliance.
This individual will lead validation and documentation efforts across multiple service locations, ensuring processes, equipment, and quality systems meet internal and external regulatory requirements.
The ideal candidate will bring strong experience in medical device process validation, equipment qualification, quality systems documentation, and cross-functional project leadership.
This role will require collaboration with quality, manufacturing, service, regulatory, and supplier management teams across a global organization.
They are ideally looking for someone who has a background in Project Management.
Responsibilities:
Lead remediation and validation activities for global service centers to ensure audit and compliance readiness.
Develop, execute, and review IQ/OQ/PQ and process verification protocols for manufacturing and service equipment.
Ensure equipment calibration, maintenance, and documentation are current and compliant.
Review and update validation documentation, SOPs, work instructions, and quality records.
Support approved supplier list updates and supplier-related documentation changes as needed.
Manage engineering change requests, documentation updates, and PLM activities within Windchill.
Coordinate cross-functional efforts across Quality, Operations, Manufacturing Engineering, and Supply Chain teams.
Provide project leadership and oversight to drive timelines, deliverables, and compliance objectives.
Support internal and external audits, including preparation and remediation activities.
Travel periodically to service centers in Latin America and Asia to support onsite assessments and implementation activities.
