Duties and Responsibilities:
- Ensure that company documents are routed, reviewed, approved, controlled and implemented in accordance with established procedures.
- Ensure the company records are retained and available for use in accordance with established procedures.
- Interfaces with various department within the company to ensure documentation accuracy and drive improvements.
- Support the transition from a paper-based document and record system to an electronic system in accordance with quality plans.
- Maintain and manage multiple projects as well as Electronic Document Management Activities as assigned.
- Attend scheduled meetings and actively participate by providing meaningful input.
- Support internal and external audit activities including FDA Inspections and ISO certification.
- Provide constant feedback and input into process improvement within the document management department.
- Be electronic document management system expert and conduct Lunch & Learn Activities on Document Management activities and requirements.
- Ensure compliance to established document control and record retention procedures.
- Maintain offsite records storage and organization.
- Ensuring that all comments/corrections submitted against a document are communicated and successfully resolved or work with the correct departments for resolution before document is published.
- Other duties as assigned.
- Comply with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations and standards.
- Bachelor’s degree highly preferred.
- Two (2) or more years of experience providing document management and record control in a regulated environment.
- Experience with using electronic Quality Management System solutions (EtQ Reliance, Master Control, Pilgrim, Agile, etc.) in a regulated environment highly desired.
- Knowledge of U.S. FDA medical device regulations (21 CFR 820) and/or International Standards (ISO 13485/ISO 9001) highly desired.
- Excellent leadership, communication, collaboration, team work and interpersonal skills.
- Superb ability to effectively communicate with staff members and business partners at all levels of the organization (both internal and external).
- Excellent computer and internet search skills.
- Strong ability to multi-task and to meet business deadlines.
- Excellent organizational skills with an ability to think proactively and prioritize work.
- The position requires the ability to perform the following physical demands and/or have the listed capabilities.
- The ability to sit up 75-100% of applicable work time.
- The ability to use your hands and fingers to feel and manipulate items, including keyboards, up to 100% of applicable work time.
- The ability to stand, talk, and hear for 75% of applicable work time.
- The ability to lift and carry up to ten pounds up to 20% of applicable work time.
- Close Vision: The ability to see clearly at twenty inches or less.
Occasional (up to 25%) travel may be required based on business need.
Company is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.