Quality Engineer

Immediate need in the St. Petersburg, FL area for a Software Quality Engineer with 5+ yrs of quality testing for medical device software. Must have a solid understanding of Quality System Regulations, ISO 13485, 60601, 62304 and other recognized international quality system and software standards and how they relate to design control, risk management, and other quality practices. This is a six (6) month contract assignment.

RESPONSIBILITIES

- Will ensure adherence to IEC 62304 on product development projects and project compliance to Product Development Process deliverables.
- Will develop and maintain QA plans and timeliness of new product development projects, as well evaluate and approve verification protocols and reports.
- Will provide support for all quoting activities by participation in initial process design, development, and implementation phases, as well manage defect identification and resolution through identified software package.
- Will manage the Design History File and its transfer to the customer with the documentation control system and manage defect identification and resolution through identified software package.
- Will interface and provide technical support on quality issues with the customer as needed.

REQUIREMENTS

- Bachelor's degree in Engineering or Computer Science required and five years related experience; or equivalent combination of education and experience
- 5+ yrs of medical device software quality and testing experience
- Solid understanding of Quality System Regulations, ISO 13485, 60601, 62304 and other recognized international quality system and software standards and how they relate to design control, risk management, and other quality practices
- Working knowledge of APQP tools. ASQ certification preferred.
- Advanced PC skills, including training and knowledge of software packages
- Ability to speak effectively before groups of customers or employees of organization
- Any software development experience is a plus, especially related to medical device software

BENEFITS

- Holidays and vacation
- Medical plan available