Quality Systems Senior Specialist (TrackWise Digital)

Integra Lifesciences Holdings Corporation • Princeton, NJ

293d • Hybrid

About The Position

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. As part of Integra's Business Systems Team, the Quality Systems Senior Specialist is a seasoned professional with complete and in-depth conceptual and practical knowledge of Trackwise Digital platform. The candidate will lead delivery of system improvements and small to moderate projects with minimal guidance and direction to achieve operational targets.

Requirements

• BA/BS degree in Computer Science or Software Engineering
• 8+ years of relevant experience in pharmaceutical/medical device industry
• 4-5 years of proven experience in an analytical or business/quality systems environment
• Technical knowledge of Trackwise Digital system is a must-have
• Expertise on Supplier Quality Management or Non-Conformance Trackwise Digital modules are nice to have
• Expertise on TrackWise On Prem, Crystal Reports, Power Apps and Power Platform are nice to have
• At least, involvement in one Trackwise Digital project implementation from project planning to go live
• Knowledge of GxP, GAMP5, 21CFR Part11 and industry best practices
• Thorough understanding of the principles of computer systems validation, SDLC methodologies and testing best practices
• Strong written and verbal communication skills ensuring the ability to interact with the business, peers and vendors in a professional manner
• Ability to work well with culturally and geographically diverse teams
• Ability to work independently with minimal supervision

Nice To Haves

• Expertise on Supplier Quality Management or Non-Conformance Trackwise Digital modules
• Expertise on TrackWise On Prem, Crystal Reports, Power Apps and Power Platform

Responsibilities

• Collecting business requirements and analyzing impacts on the existing solution
• Applying knowledge of Trackwise's best practices to internal processes to make recommendations for system design
• Developing and configuring new and existing processes including analyzing business processes, evaluating user requirements and system specifications, process flows, group categories, terminology, states and activities, permissions, login accounts, record types and settings
• Supporting business users during User Acceptance Tests execution
• Reviewing scheduled system releases/upgrades and determining impact on Quality processes, system configurations, customizations
• Working on issue resolution, coordinating with support teams or vendors when necessary
• Working with IS peers on the integration of Trackwise platform within the Integra IS landscape
• Creating validation deliverables such as test scripts, URS documents, FRS and Configuration Specification documentation following Integra's Computer System Validation and Change control process to maintain the system in a validated state

Benefits

• Equal employment opportunities regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status
• Commitment to provide reasonable accommodations for disabled veterans or individuals with disabilities

What This Job Offers

• Career Level: Senior
• Industry: Management of Companies and Enterprises
• Education Level: Bachelor's degree