Changing lives. Building Careers.
 

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.

To perform this job successfully, the individual must be able to perform each essential duty satisfactorily:

Solves complex problems exercising judgment based on the analysis of multiple sources of information.Understands business challenges, provides recommendation on Trackwise functionalities to cover the Quality processes (CAPA, Audit, Complaint, Supplier Quality Management, Non-Conformance…) and contributes to process improvements.Works to build consensus within cross functional project teams.Shares their Trackwise expertise with support team and business Subject Matter experts.Leads system improvements and small to moderate projects with minimal guidance and directionConsiders operational constraints and regulatory factors for solution delivery as per project initial scope, budget and planning and in respect of internal processes for project computer systems validation and change control management.

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

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 teamsAbility to work independently with minimal supervision.

Additional details:

This role is hybrid between Princeton, NJ and remote. Office days are Tuesday, Wednesday and Thursday.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law | EOE including Disability/Protected Veterans

Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.

Integra - Employer Branding from Integra LifeSciences on Vimeo