Product Software Quality Engineer

Looking for experienced Software Quality Engineer well versed in the medical device industry, specifically in the area of Product Software development for medical devices. This person is responsible for providing Quality Assurance review, oversight, guidance and direction for the development of the Product Software contained within the device or stand-alone software.

Product 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. Must have the background to understand the deliverables fully and provide interactive feedback in reviews and approvals of validation documentation. Responsible for compliance with applicable corporate policies and procedures as well as external regulations such as the CFR's 820's, 807, 814 etc., EC Directive 93/42/EEC Medical Devices, including applicable MEDDEV Guidelines, 21 CFR Part 4A Current Good Manufacturing Practice Requirements for Combination Products.

SKILLS:

- 10 years' experience covering entire product software life cycle in a team oriented environment
- Provide quality support and assurance for software development activities.
- Ensure safety and quality of the software products developed by managing the software product life cycle activities
- Ensure compliance, alignment and consistency with the company's corporate quality system, regulatory and standard requirements
- Provides strategic compliance decisions and direction to teams, functions and/or the organization with little supervision or oversight
- Assist and/or guide software requirements generation and associated verification strategies
- Participate and support design reviews, test readiness reviews, code reviews, and unit test inspections
- Perform and support software risk analysis and management
- Expertise in design controls (21CFR820.30), product realization (ISO13485 and IEC 62304) and Risk Management (ISO 14971)
- Experience with Agile Development
- Deep working experience with IEC 62304 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.