Overview
On Site
Contract - W2
Contract - 12 Month(s)
Skills
Standard Operating Procedure
Forms
Supervision
Attention To Detail
New Product Introduction
Clinical Trials
Accessibility
Version Control
Distribution
Reporting
Documentation
Supply Chain Management
Regulatory Compliance
Auditing
Document Review
Technical Support
Problem Solving
Consumer Electronics
Management
Quality Management
System Documentation
Teamcenter
Plant Lifecycle Management
Product Lifecycle Management
Document Management
Medical Devices
ISO 13485
Health Insurance
Insurance
Team Building
Collaboration
Wiki
Knowledge Base
Status Reports
Account Management
IT Consulting
Managed Services
Recruiting
Artificial Intelligence
Cyber Security
Enterprise Architecture
Training
FOCUS
Job Details
OP, we're more than a consulting firm-we're a people-first, high-touch organization committed to delivering transformative technology solutions with integrity and passion. Currently, we are seeking a well-experienced Document Specialist who will support product programs by managing Standard Operating Procedures, Work Instructions, Forms, and all types of Records from product concept through obsolescence. The Document Specialist has knowledge and experience working in regulated environments (i.e., ISO 13485) and sufficient knowledge and experience to be able to operate with minimal supervision. You are flexible, responsive, detail-oriented, hands-on, and able to manage competing demands.
Responsibilities:
- Support Quality Management System documentation and records through the product lifecycle.
- Create and release documents based on input from quality and compliance teams to support new product introduction, production product releases, clinical trials, and FDA submission.
- Ensure documentation and data related to the requirements of the Quality System are controlled in a manner that ensures integrity and accessibility.
- Ensure document control activities such as document management, version control, distribution, and reporting management are executed in a timely fashion and by regulatory requirements.
- Collaboratively communicate documentation and records requirements between Operations, Supply Chain, and Engineering to facilitate compliance to applicable medical devices standards.
- Maintenance of all applicable records such as validation reports, test reports, exit reviews, and test results, as defined by applicable regulations and standards.
- Support audits for licensure and accreditation documents submission.
- Support the maintenance of documents resulting from periodic document review.
- Manage and organize complex projects and priorities, solve problems that impact release progress, and provide detailed information to cross-functional teams.
- Support the implementation of the new eQMS.
- End-user support and problem resolution.
Qualifications:
- 5+ years of related experience in a high-tech, fast-paced, consumer electronics environment managing medical device Quality Management System documentation and resulting records.
- Experience with Teamcenter or related PLM/Document Management systems.
- Experience working in a regulated Medical Device environment.
- Familiarity with Google Suite.
- Familiarity with ISO 13485.
Benefits:
- 401(k).
- Dental Insurance.
- Health insurance.
- Vision insurance.
- We are an equal opportunity employer and value diversity, equality, inclusion, and respect for people.
- The salary will be determined based on several factors including, but not limited to, location, relevant education, qualifications, experience, technical skills, and business needs.
Additional Responsibilities:
- Participate in OP monthly team meetings, and participate in team-building efforts.
- Contribute to OP technical discussions, peer reviews, etc.
- Contribute content and collaborate via the OP-Wiki/Knowledge Base.
- Provide status reports to OP Account Management as requested.
About us:
OP is a technology consulting and solutions company, offering advisory and managed services, innovative platforms, and staffing solutions across a wide range of fields - including AI, cyber security, enterprise architecture, and beyond. Our most valuable asset is our people: dynamic, creative thinkers, who are passionate about doing quality work. As a member of the OP team, you will have access to industry-leading consulting practices, strategies & and technologies, innovative training & education. An ideal OP team member is a technology leader with a proven track record of technical excellence and a strong focus on process and methodology.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.