Job Details
Title: Documentation Specialist - Onsite
Description:
This position is responsible for reviewing and processing change requests for new documents and revisions to existing document. This includes processing, organizing, and maintaining document control administrative functions of the product lifecycle management application to ensure applicability to governing procedures and regulations.
We are seeking contingent support for a Document Control Specialist assignment. This person will be responsible for the evaluation and administration of electronic controlled quality records in accordance with regulatory requirements and company policies. Must have strong organizational skills, the ability to meet deadlines, thrive in a fast-paced environment and be able to problem solve effectively. This assignment will be managed by the QA Change Control Manager.
Responsibilities:
Receive and coordinate requests for processing and approval of engineering design documents in a controlled product lifecycle management system.
Complete assigned tasks by monitoring progress and performing follow-up activities to ensure successful completion of document control activities.
Perform evaluation of engineering documentation supporting identified projects.
Resolve document control issues and discrepancies.
Ensure compliance to site level policies and procedure by promptly reporting non-compliance issues to the department manager or team leads.
Must be able to work independently and effectively with various quality and engineering functions.
Performs other duties and tasks as required.
Participate on cross-functional teams and coordinate change record or design plan approvals as needed.
Adhere to Employee Health and Safety procedures for the facility.
Qualifications:
High School Diploma or equivalent required. A minimum of four years administrative or medical device industry experience preferred.
Preferred Experience:
Knowledge and proficiency of electronic document control systems.
Knowledge of engineering documents and change control processes will enhance execution of the deliverables.
Proficiency with Outlook, Word, Excel, PowerPoint, Acrobat, and other software tools, you will efficiently track engineering packages
Strong verbal, written, organizational, time management and interpersonal skills.
Note :
8:30 AM - 5.00 PM