Qualifications

• Minimum five (5) years of relevant experience in equipment/systems lifecycle management for medical devices.
• Expertise in validation documentation, including User Requirement Specifications and Validation Determination Assessments.
• Proven skills in managing validation protocols and discrepancies related to clinical operations.
• Experience collaborating with operations teams to align user needs with validation processes.
• Familiarity with electronic asset management systems, especially Blue Mountain RAM.

Responsibilities

• Develop and execute various validation documents to support equipment lifecycles.
• Serve as the primary on-site contact for validation contractors during project execution.
• Review and pre-approve validation documents to ensure timely QA approval.
• Lead the documentation process for protocol discrepancies and assist in related investigations.
• Collaborate with teams to maintain and update validation documents based on user needs and operational changes.
• Ensure the validated state of equipment is maintained post-calibration/maintenance activities.
• Manage the equipment/asset tracking process using Blue Mountain RAM.

Benefits

• Collaborative work environment with a focus on process improvement.
• Opportunity to support cutting-edge medical device technology.
• Engagement with multiple departments, enhancing cross-functional skills.
• Chance to lead and influence validation strategies in a clinical environment.
• Access to professional growth and learning opportunities within the organization.