FDA Regulated Industry Software Quality SQE Validation Consultant

We have been engaged by our client, a large high profile FDA regulated industry company to provide an FDA Software Quality andQUALITY SYSTEMS  Software Quality Consultant .  Familiarity with software systems and software development validation experience is a strong plus. Ability to evaluate code and determine if supervised vendors work is compliant to client's quality system requirements.

 

Duties and Responsibilities:

• Plays key role in providing full guidance and direction on acceptability of Software Quality deliverables, based on requirements and templates given and following the correct corporate policy requirements.
• Acts as an effective team member who provides independent review on deliverables used to develop, implement and maintain manufacturing and Quality software.
• Communicates the value of the Software Quality process and champions departmental or cross-functional software Quality Assurance initiatives.
• Ensures buy-in from project team members to the disciplines, decisions and practices of the Software Quality organization
• Proactive involvement in continuous improvement activities for the software Quality life cycle while ensuring that company’s software systems are defensible for regulatory requirements.
• Develops, modifies, applies and maintains standards for Software Quality methods, processes and procedures which meet company's and external regulatory requirements and implements against them.
• Establishes methods for monitoring the compliance of software system processes, standards and procedures.
• Provides expertise on software validation requirements to project teams that are implementing software systems and provides independent review to teams.
• Teaches and coaches less experienced colleagues and executes on projects along with other members of the Software Quality team.
• Functional engineering role includes manufacturing and Quality software and computerized system validation and maintenance.

Skills required:
• Able to clearly define the methods for complying with regulations that apply to Quality Systems and Manufacturing Systems software.
• Able to provide direction to software/computer system development teams on the requirements for complying to corporate policies
• Able to design, implement and present training that effectively educates individuals on good software engineering practices and compliance requirements.
• Good interpersonal skills needed to manage and resolve issues from different business cultures.
• Fundamental understanding of software/computer systems life cycle activities.
• Fundamental understanding of software/system configuration management and change control
• Fundamental understanding of GMP/QSR requirements preferred.

Education and Experience:
• 5 to 8 years experience in software system validation or equivalent within software sciences
• Experience must include project management
• BS degree in software sciences. MS preferred  

Medical Device background a strong plus.

 

Work initially is approximately up to 40 hours per week. Potential for offsite work is possible as work transitions to possibly less than 40 hrs per week.