Description

The Document Control Specialist works under direct supervision coordinating, implementing, and maintaining the company's document/change control system, while established procedures and policies needed to meet the demands of document control in a regulated medical device company. Responsible for planning, developing, and coordinating company-wide training program in accordance with applicable laws and regulations.

Responsibilities:

• Assist in developing/redlining procedures.
• Guide Document Control Associate/Coordinator team members.
• Drive a culture of continuous improvement and reporting metrics.
• Track and facilitate timely documentation review and implementation.
• Ensure documents and records are retained per company procedures.
• Identify and solve problems using established bushiness rules and procedures.
• Ensure integrity and accessibility including photocopying and scanning
• documents.
• Incorporate document changes and release of all current and inactive controlled documents in electronic formats. 
• Review Quality Records for adherence to Good Documentation Practices (GDP) and compliance to governing procedures.
• Review change orders and associated documentation to ensure compliance to company document and change control procedures.
• Support all company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements.
• Collaborate cross functionally to support the creation of documents in alignment with requirements; and issue resolution of discrepancies when required to meet requirements.
• Verify completion of DCO/ECO/MCO-related activities, such as material disposition and training to ensure closure of DCO/ECO/MCO following completion of these activities.
• Maintains quality training requirements in compliance with applicable regulatory. regulations, company policies, and internal procedures.
• Assists departments in defining training requirements and determining timelines.
• Collaborates with hiring managers to develop training plans.
• Manages training plans for all functional areas.
• Maintains and updates training records (digital and electronic).
• Perform other related duties and projects as business needs require at the direction of management.

Qualifications:

• High attention to detail.
• Prioritize work/projects.
• Possess strong interpersonal skills.
• Strong organizational and interpersonal skills.
• Self-auditing and have high quality standards.
• Strong verbal and written communication skills.
• Bachelor’s degree in Science, Engineering Biochemistry, Biotechnology, Biology or Biomedical Engineering.
• Minimum 5 years’ experience in Document Control and/or Quality Systems.
• Proficient in the use of Microsoft Office 365.
• Read, understand, and relay technical information accurately and concisely
• Fluently bilingual both written and verbal

Inari Medical, Inc. advises applicants that employment is subject to completion of a successful background check.