Software Quality & Validation Consultant

Title: Software Quality & Validation Consultant

Location: Onsite 5 days Andover, MA (Local Only)

Job Description

• Strong with quality software validations
• Strong/recent Med device industry experience is preferred, if not then pharma or biotech works. Any is required
• Will be supporting ongoing projects from the quality validation size initiatives
• Needs someone that can work cross functionally with the IT team

Will be supporting ongoing projects from the quality validation size initiatives

Needs someone that can work cross functionally with the IT team

Sizzle:

Overview: The ideal candidate will have a strong background in quality processes and IT

Key Responsibilities:

• Collaborate with quality teams and IT to manage dependencies and ensure seamless integration.
• Help Digitize and streamline existing paper-based processes, handling approximately 300 MCRs per month.
• Attend meetings, engage with consultants, and provide granular-level guidance throughout the implementation.
• Build a global architecture to support the organization's expanding manufacturing footprint.
• Communicate effectively with vendors and stakeholders, ensuring flexibility and adaptability.
• Drive the project proactively, bringing together cross-functional teams and anticipating potential challenges.

Required Qualifications:

• Proven experience with a strong understanding of quality processes and IT interfaces.
• Ability to work cross-functionally with quality teams, IT, and other stakeholders.
• Strong organizational skills, with the ability to manage complex projects and timelines.
• Experience in building global architectures and supporting global manufacturing operations.
• Excellent communication and vendor management skills.
• Ability to navigate and resolve issues as they arise, working proactively to drive the project forward.
• Strong soft skills, including the ability to assimilate with various groups, work collaboratively, and break out of their shell.

Preferred Qualifications:

• Experience in automating manufacturing processes and moving to a global manufacturing footprint.
• Business expertise to drive the project and bring everyone together, looking around corners to anticipate challenges.

Soft Skills:

• Ability to work cross-functionally and navigate difficult processes.
• Problem-solving skills and the ability to resolve issues as they arise.