Description
Summary- This person is responsible for providing Quality Assurance review, oversight, guidance and direction for the qualification of the Product Software contained within the device or standalone software.
- Responsibilities include reviewing the Software Development Life Cycle activities from the planning phase, through design verification and validation and all of the in-between activities.
- Responsible for compliance with applicable corporate policies and procedures as well as external regulations.
- Provide quality support and assurance for software verification and validation activities.
- Assist and/or guide software requirements generation and associated verification strategies
- Expertise in design controls, product realization, and Risk Management.
Qualifications
- Looking for Quality Engineer well versed in the medical device industry, specifically in the area of Design Verification for medical devices.
- Must have the background to understand the deliverables fully and provide interactive feedback in reviews and approvals of software development documentation.
- Experience working with IEC 62304 is desired.
- Experience supporting Design Verification and Validation activities is required.
- Comfortable leading/actively contributing to risk based evaluations using tools such as FMEA, FTA and Risk Analysis.
- Experience working with Third Party Manufacturers is a plus.
- ASQ certified Software Quality Engineer is a plus.
- 5 - 7 years' experience in a team oriented environment