Document Control Coordinator
Document Control Coordinator
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Job Description
Description:
As a Document Control Coordinator on our Fluke Health Solutions Quality Assurance/Regulatory Affairs team you will be responsible for the administration of the quality document control process and ensure alignment with applicable standards and country specific regulations. You will be a champion for quality and compliance in our business integrating into all design and manufacturing functions to streamline documentation processes. This person will administrate the quality software system ensuring documentation is maintained and compliant for business needs.
Your primary contacts will be:
Internal:Quality Assurance and Regulatory Affairs team Operations team Engineering team Business Units as well as all other functional team members.
External:Customers Notified Bodies or Suppliers
Responsibilities:
- Administrate quality software system and document control process including acting as project manager to lead minor change control projects.
- Coordinate and maintain controlled documentation both physically and electronically according to approved procedures.
- Assist with file migration to storage both physically and electronically as applicable.
- Coordinate and execute the migration of legacy documentation stored outside of the existing eQMS into a new eQMS system
- Ensure all documents are current properly identified and maintained per applicable standards and regulations.
- Aid in investigation and improvement initiatives for quality processes.
- Review records and documents for completeness and compliance with FDA Quality System Requirements and ISO requirements.
- Assist in companywide training on general quality principles and specific procedural requirements.
- Other activities as assigned by supervision including crosstraining in other areas of quality and regulatory as applicable.
- Develops and reports document control change control and training key performance indicator metrics and change management statistical information to management team.
- Assist and support internal audits and agency inspections/audits.
Qualifications:
- Minimum of a bachelors degree in a life sciences healthcare or technology discipline (Preferred)
- Relevant experience in the medical device industry is required
- Familiarity with FDA medical device regulations and ISO 13485 is required
- Experience in QA document control process administration required
- Experience with effective project management preferred
- 3 years with Document Control experience working in an eQMS platform (e.g. Propel PLM Oracle Cloud Arena PLM or SoftExpert)
- Ability to read and interpret general technical/quality procedures and quality system regulations
- Ability to write and create medical device manufacturing SOPs and Work Instructions
- Ability to effectively present information and respond to questions verbally in writing and in group presentations
- Must be skilled in Microsoft Word Excel Outlook and Power Point
Position Type/Expected Hours of Work
- This is a fulltime position 40 hours per week. Days and hours of work are Monday through Friday during business hours.
- This position will start out onsite however a hybrid schedule will be considered after a few months for this role.
Travel
- No significant travel should be expected for this position
Required Experience:
IC
Employment Type
Full-Time
