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Quality Systems Technical Lead

ConvaTec

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Job Snapshot

Location:

Princeton, NJ 08540 ( map it!

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Employee Type:

Full-Time

Industry:

Pharmaceutical

Manages Others:

Not Specified

Job Type:

Information Technology

Experience:

Not Specified

Travel:

None

Post Date:

11/5/2009

Contact Information

Ref ID:

INF00015

Description Key Responsibilities & Expected Areas of Competence

Application Development and Support
- Analyze and interpret complex technical problems and processes. Identify the key requirements for solving the problems and present alternative solutions.
- Use mastery of programming languages or Commercial-Off-The-Shelf (COTS) software applications to develop new technical solutions.
- Provide technical support for several business critical systems. Track reported issues and ensure timely resolution within the appropriate service level agreement.
- Coordinate with vendors, consulting service providers, and internal resources to implement new software functionality and address on-going support issues.

Communication and Stakeholder Management
- Organize and present ideas with clear and concise verbal and written communication. Exhibits confidence when communicating issues, ideas, or subject matter expertise.
- Take personal responsibility for results and focus on setting clear expectations for key stakeholders and peers within the organization.
- Develop and maintain strong working relationships with key stakeholders and maintain a focus on customer service and support.
- Balance conflicting priorities and demands between new system implementations, enhancements, and application support.
- Directly interact with business owners within the Quality, Environmental Health and Safety, and Regulatory departments in the organization.

Project Management and Software Development Lifecycle
- Implement standards and methodologies associated with software management, development, and monitoring progress.
- Knowledge and understanding of project management methodologies and applying them to software development implementations.
- Work with end users to understand, verify, and develop requirements.
- Interpret business requirements and devise technical solutions. Use analytical techniques to identify issues, develop and evaluate alternative solutions.
- Demonstrate ability to complete multiple, simultaneous projects with minimal supervision while motivating team members to achieve business objectives.

Compliance with Policies and Procedures
- Use and ensure adherence to software testing and quality assurance processes required for Computer System Validation (CSV).
- Prepare system design documentation, system test scripts, and other documentation needed for system change control.
- Maintain appropriate system documentation and software code within a controlled repository.

Requirements Experience Desired

At least 5 to 7 years of experience in Information Technology. Experienced related to the medical device or life science industry is preferred.
Applied knowledge in all phases of software development lifecycle.
Exhibits ability to effectively drive performance and implement innovative technical solutions.
Strong technical background in Microsoft and Java based application development technologies and architectures.
Strong technical background in relational database design, queries, and report building using tools such as Crystal Reports and SQL Navigator.
Knowledge and experience with quality management systems especially TrackWise.
Applied knowledge of software testing and computer system validation.
Demonstrates ability to effectively communicate with IM technical staff, solution partners, and key stakeholders within the organization.
Proven skills in systems design and development techniques utilized in the execution of technical projects.
Highly organized and proven ability to lead small to medium sized teams during the execution of technical projects.
Understanding of business processes related to Quality Management, Environmental Health and Safety (EHS), and Regulatory practices in the medical devices industry.
B.S. or Bachelors degree required. Masters in a related science or engineering field preferred.

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