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Project Lead QA Document Management

Company: CorTech LLC
Location: Des Plaines
Posted on: March 10, 2023

Job Description:

CorTech is seeking to hire a Project Lead QA Document Management for our client in Des Plaines, IL!
Benefits Available!
Weekly Pay!
Start Time (AM/PM)
7:30 AM
End Time (AM/PM)
4:00 PM

This is a non-exempt position. This position is responsible for executing and maintaining software quality engineering methodologies and providing quality engineering support for software utilized throughout the division.
Duties: Develop and conduct training of company personnel for the divisional software development and validation program. Work with Design and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes. Create and execute or direct software validation protocols traceable to system/software requirements. Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems. Assist in the completion and maintenance of risk analysis, focused on software related risks. Design and implement various product and process improvement methodologies (ie Six Sigma and Lean Manufacturing). Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating, and resolving issues. Software scoping and Part 11 audits. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Performs other related duties and responsibilities, on occasion, as assigned. BS degree in Engineering or Technical Field or equivalent experience. Qualifications: At least 7 years Software Quality Engineering experience. Detailed knowledge of FDA, GMP, IEEE 1012 and ISO 13485. Advanced computer skills, including statistical/data analysis and report writing skills. Advanced Information Technology and data mining skills. Prior medical device experience preferred. ASQ CSQE certification desired. Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail. Ability to travel approximately 5-25%, including internationally. Ability to maintain regular and predictable attendance.

This position is responsible for participating in defining and implementing the Client : Molecular Diagnostics (MDx) Document Management System Upgrade Project.

Position Responsibilities:
Reviewing and processing change requests in the IQVIA SmartSolve SmartDoc system for new documents and revisions to existing documents and controlling access of documentation as required by procedures and regulations.
Ensuring that any new documents or changes to existing documents are appropriate, justified, and approved by the required functional areas according to established procedures.
Interpret the needs of the various internal customers and strive to meet those needs.
Work directly with management to develop and deliver site guidance on document management processes and roles for the new system.
Updates and maintains document control procedures and participates in the development/improvement and roll-out of document control tools.
As assigned, participate in committees and projects, implement changes, and delivers per the project plan related to the document management system upgrade.

Position Accountabilities:
Contribute to ongoing process improvements with focus on document accuracy, efficiency, and regulatory risk mitigation.
Collaborate with associates inside and outside the organization to assess and enhance change control systems, per project details.
Accountable for the integrity and maintenance of the Division Document Control system.
Interact with all levels and functional areas of the organization including Manufacturing, Quality, Purchasing, Planning, Marketing, Labeling, Regulatory and R&D.
Responsible for ensuring that procedures are established, followed, and maintained in compliance with documented procedures and regulations.
Execute document control decisions following established procedures and guidelines without prior review with immediate manager.
Effectively communicates action items to manager for additional approval when necessary.

Educational / Skills/ Experience:
BA/BS degree preferred in computer science, business, or related field, or relevant job experience.

The minimum knowledge, skills, and experience requirements of the position include:
Preferred supervisor or project management experience related to IT project implementation.
Advanced word processing experience with working knowledge of Microsoft Office
Works independently and demonstrates organization skills with the ability to manage multiple tasks and prioritize accordingly.
Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
Strong leadership, organizational, follow-up, collaboration, accuracy, analysis, communication, writing and analytical skills.
Experience in Document Control, preferably in client-facing design and construction of large infrastructure projects.

Keywords: CorTech LLC, Des Plaines , Project Lead QA Document Management, Executive , Des Plaines, Illinois

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