Responsible for Computer System Validation (CSV) activities for all departments which rely in CSV services. Duties will include but are not limited to:

• Ensuring CSV is performed according to business policies and procedures as well as legal requirements and any requirement set by regulatory authorities.
• Ensure that the gobal software inventory and validation master plans are established and up to date for all ongoing projects, applications, and hardware infrastructure.
• Coordinate and plan system validation tasks in line with a proposed change or project.

This experienced candidate will be overall responsible for coordinating and leading CSV activities globally. The candidate will have a solid fundamental background in CSV, project management principles, leadership, and business acumen.

In this key role, you will work extensively with the Invacare subject matter experts and technical resources. You will be responsible for leading CSV activities, resource planning, and ensure formal governance and cadence throughout the organization in relation to CSV.

Responsibilities

• Maintain the global software inventory
• Assess and lead CSV on assigned projects.
• Take accountability for the work produced by yourself and other colleagues.
• Plan, co-ordinate and execute all phases of CSV for production and QC systems in all regions and entities of the organization including but not limited to, Validation plans, RTM, IQ, OQ, PQ and Validation Reports.
• Perform CSV periodic review of validated systems.
• Assist in the preparation and approval of technical and GXP related documentation.
• Coordination and oversight of external subcontractors and software suppliers when required.
• Handling of Change Requests, CAPAs and Non-Conformances related to CSV.
• Contribute to ensure that changes are introduced into the organization efficiently and effectively.
• Lead a cross functional team to achieve project requirements, deadlines, and schedules.
• Responsible for consistent, accurate and timely information to all appropriate internal and external stakeholders through a variety of communication channels.
• Performs other duties as assigned.

Qualifications

• Bachelor’s degree in Information Systems Technology, Computer Science.

• A minimum of 3 years’ experience with CSV inside a medical device regulated business.

• Experience on validating software & hardware infrastructure (e-g: servers, network, applications, and software services).

• Strong ability to prioritize, plan, and organize tasks.

• Excellent communication skills.

• Ability to work under minimal supervision.

• Ability to assess priorities and work well under pressure in a fast-paced environment.

• Ability to effectively work as part of a multidisciplinary, international team.

• Knowledge of working in a GxP environment.

• Knowledge of quality assurance principles.

• An Equal Opportunity/Affirmative Action Employer –M/F/Disabled/Vet

Required Skills

Required Experience

• Proven proficiency with computerized warehouse business systems
• Excellent problem-solving skills
• High degree of organization, accuracy and dependability.
• Ability to work in a team environment required.
• Must be able to lift 30 lbs with or without an accommodation
• Ability to work overtime as needed
• Ability to follow the requirements of documented processes as defined in the ISO Quality Manual.