Computer Software Validation Specialist. Suecia

We are looking for an enthusiastic, talented Computer Software Validation Specialist!

Invacare is a leader in the manufacturing, sales and distribution of a complete package of innovative home and long-term care medical products that make a difference to people’s lives.

In this key role, your mission will be to work extensively with and support the CSV Lead, Invacare subject matter experts and technical resources. You, along with the CSV Lead, will be responsible for driving CSV activities, and ensure formal governance and cadence globally throughout the organization in relation to CSV. You will be working closely with the Quality & Regulatory Affairs Department.

Key responsibilities:

• Help maintain the global software inventory.

• Working with CSV lead on assessing CSV on assigned projects.

• 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.

Qualifications:

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

• A minimum of 2 years’ experience with CSV inside a medical device regulated business.

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

• Knowledge of working in a GxP environment.

• Knowledge of quality assurance principles.

You have a solid fundamental background in CSV, project management principles, and business acumen. During your career, you have demonstrated leadership, pragmatism and the ability to coordinate teams.

You will be part of a multidisciplinary, international team. Your autonomy, your problem-solving capacity, your ability to anticipate and structure your activity in a fast paced environment, as well as your communication skills, will be important assets to carry out your mission successfully.

Interested?

This position will report to the CSV Lead in the US, and can be based anywhere in Europe. Please send your application in English to us here. We would like your application no later than 18 February 2024. We are interviewing continuously and might close the ad earlier, so don´t wait to apply!