Software Quality Assurance Manager

SUMMARY:  Support Product Development teams with Software Quality Assurance Compliance and Product Approval

 

DUTIES:

 

1.  Participation as core team member in Software Development from Design Input phase through project completion and product release.

 

2.  Design Controls Compliance to GSDP & GSDCC, product specifications, risk management, verification and validation, clinical studies, etc.

 

3.  Responsible for consulting on GAMP IV implementation.

 

4.  Training of project teams in requirements and providing milestones and submission timeframes with estimates of completion.

 

5.  Document regulatory assessments and letter to file rationale as appropriate

 

6.  Provide documentation review and feedback in real time to project teams regarding content accuracy or completeness.

 

7.  Review  for regulatory requirements in terms of Open source and I.P

 

8.  Degree of concern assessment of software anomalies based on FDA Guidance.

 

9.  Maintain knowledge of standards applicable to products for design input.  Understand, interpret, and disseminate knowledge regarding new or changing standards to those affected. This includes basic safety, particular standards for specific medical requirements in Software.

 

 

 

 

EDUCATION & EXPERIENCE: BS in Computer Science.  5+ years in Software Systems management, design control with experience in risk assessment and V&V protocol review.  Must have a working knowledge of FDA submission requirements and applicable software development standards.  Excellent written, verbal and presentation skills.