QA Lead- Software Validation to Medtech company
Would you like to work in a growing and fast paced, global Medical Device Swedish company located in Gothenburg city center? Are you interested in working with intelligent products that are intuitively simple to use? Do you want to take the lead position for the Software Validation within the company? If so this exciting position may be for you.
If you aspire to help create and innovate whilst developing yourself in a challenging team setting, Neoss may well have the perfect conditions for you to grow.
We welcome you to a workplace with inspiring challenges where the meeting between competence and personality builds the foundation for our success. We believe that an open environment, where everyone's opinions and ideas are welcome, is a prerequisite for our future development.
In this position you will take the lead role for the Software validation within Neoss. You will have the responsibility to create and develop the validation system for the software validation.
In this newly created role at Neoss you will work closely with the Quality Assurance Manager and the IT manager, and you will also have a close cooperation with the Quality Assurance team, Product Development team and the technical marketing team.
- You will Lead in the creation and execution of validation documentation for hardware/software on existing electronic systems and new electronic systems.
- Maintain the validated status of systems through the management of the IT Change Control process to assess proposed changes, and then approve, implement and release.
- You will lead the management of the validation master plan. This will include the drafting of applicable validation documentation relating to IT hardware and software (USR, FDS, IQ, OQ, POs). It will also involve in the execution and documentation completion associated with the validations. Scope relates to new hardware/software and in the validation/revalidation of existing systems.
- You will Lead/support the IT/Quality Assurance Manager in the future projects related to software/hardware development and changes.
Who are you?
We think that you have:
- Minimum BSc degree in IT/Quality or other relevant qualification.
- Two plus years in working in a lead role within software validation primarily within the medical device and/or pharmaceutical industry. This will involve the creation and execution of validation/revalidation documentation associated with IT hardware and software.
- Working with the validation and maintenance of IT hardware and software used across sites/countries is a distinct advantage.
- In depth knowledge/understanding of ISO:13485 'Medical devices - Quality management systems - Requirements for regulatory purposes 2016' from a software validation perspective is a distinct advantage.
- In depth knowledge of FDA 21 CFR Part 820/QSR, and in particular 21 CFR Part 11; Electronic Records; Electronic Signatures Validation' is a distinct advantage.
- In depth knowledge/understanding of ISO TR 800002-2 2017 'Medical Device Software-Validation' is a distinct advantage.
- General understanding of Medical Device Directive 93_42EEC and upcoming Medical Device Regulations 2017-745 would be helpful.
Who are we?
Neoss offers intelligent products that are intuitively simple to use. Our products allow dental professionals to provide reliable and cost-effective treatments to their patients with excellent long-term results.
Lead the market with ingenuity and integrity in which we strive to set new standards.
We develop smart treatment solutions in consultation with specialist practitioners to make the complex less complicated. We call that Intelligent Simplicity.
This recruitment process is cooperation between Experis and Neoss. Experis is a part during the process but you will be hired directly at Neoss. If you have any questions please contact recruitment consultant Adam Grundqvist at firstname.lastname@example.org or +4631617253 or recruitment consultant Thandi Schüler at Thandi.Schuler@se.experis.com or +46725065169.