The project Design Quality Engineer will be responsible for implementing and maintaining the Software as a Medical Device (SaMD) design controls and software design history file records for SaMD projects. You will be the sole quality engineer for the projects responsible for leading quality software activities across the group.
- Review and approve Software deliverables for the projects, such as Problem Reports, Change records, Risk files, Test protocols and reports.
- Lead software quality activities for significant changes and new requirements for Enabling Technologies and software systems
- Provide guidance and expertise on software development process, procedures and practices.
- Support regulatory filings and inspections
- Provide technical support for audits of Software Suppliers and Software Consultants.
- Perform all job duties in full accordance with the Worldwide Policies on Information Asset Protection, maintain password(s) as Confidential, and protect Critical Business Information
- A Bachelor’s Degree in Engineering, Computer Science, Information Systems, Biomedical/Bioengineering Degree preferred.
- A minimum of 3 years of regulated industry experience in a quality, new product development, or manufacturing engineering capacity is required.
- Expertise in applicable industry standards and regulations including, but not limited to as IEC 62304, FDA guidance, FDA Part 11, ISO13485, ISO14971, IEC 62366-1.
- ASQ certification as a Software Quality Engineer is preferred.
- Demonstrated performance with managing cross-departmental projects is required.
- Highly competitive to match experience and capability