Quality Systems Analyst (631361)
Parsippany, NJ

Job Description

Responsible for reviewing and approving validation deliverables of GxP regulated computerized systems to ensure full compliance with Medical Device regulatory requirements and adherence to company policy and procedures by supporting computer validation projects and base business support teams.

This position has responsibilities of participation in the conceptualization, development, testing, and subsequent deployment and standardization of computerized systems for Quality and Manufacturing Excellence.

Principal Duties and Responsibilities

Project Management

* Provide Project management functions for implementation of small to large scale solutions through: Development and maintenance of detail project plans, Organization of project implementation team, Project budget management, Go live planning and execution

Technical evaluation and design

* Perform pre and post review and approval of validation test scripts including test defects
* Review/approval of validation documentation deliverables such as but not limited to Compliance Plans, User Requirements, System Tests, User Acceptance Tests, Traceability Matrix, and the Compliance Report including final release and approval for production use.
* Develop and document process and procedures for systems.

Technical implementation

* Understanding business needs and working with cross-functional teams to customize software and systems.
* Provide SME guidance and training relative to the use of IT solutions to support manufacturing at TMT.
* Develop in-depth knowledge and understanding of manufacturing and quality system software.

Data Analysis

* This position will be responsible for pulling data and preparing reports for quality trending purpose.

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

Expected Areas of Competence

* Demonstrated ability to work successfully within a team and build effective working relationships
* Demonstrate strong skills in communicating technical ideas to non-technical personnel
* Stays abreast of relevant technologies and business processes and provides input to the development and implementation of the global systems and automation strategies
* Has an understanding of ERP, MES, Infinity QS or other SPC tools and Demand Planning applications, technology utilities, (database structures, EAI tools, solid programming logic), factory automation, global project management and conversation/ interface strategies and techniques
* Continuous improvement and results orientation; acts with a sense of urgency and delivers results on-deadline
* Effective interpersonal, influence and communication skills (written/verbal/presentation); appropriately shares viewpoint and encourages the free exchange of information and opinions
* Effective analytical, organizational and critical thinking skills
* Demonstrates strong project management and work planning skills; must be able to multitask effectively
* Willingness to embrace change and adapt to new circumstances

Education/Experience Requirements

* Bachelor's degree in Computer Science, Information Technology or related field required
* 1 or more years experience in Manufacturing Systems/Quality System/Project Management related experience strongly preferred. Company internships a plus.

Travel Requirements

* Up to 10%

Additional Information

* EOE M/W/Vet/Disability

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