POSITION SUMMARY:

This position will ensure the AtriCure Document Control system is compliant with domestic and international medical device quality system regulations. The Quality Systems Supervisor will assist in the management and establishment of policy in the document control and record retention systems. The Quality Systems Supervisor is responsible for leading and coordinating the activities of the Document Control team. This position can answer daily questions for the AtriCure organization regarding the document control system (i.e., MasterControl, PLM), record retention and document control. In the role of the Quality Systems Supervisor, this person will work with the entire AtriCure organization to ensure compliance with the AtriCure quality system and will be responsible for reporting to management issues revolving around quality system compliance. The Quality Systems Supervisor is responsible for identifying and implementing state-of-the-art solutions for document control, records management, and external standards maintenance/administration.

ESSENTIAL FUNCTIONS OF THE POSITION:

• Responsible for leading the configuration management and software validation of the quality software system.
• Responsible for identifying and implementing process improvements to the document control system
• Responsible for processing Document Change Notices or Advanced Task Packets through the quality system
• Responsible for quality systems records filing, maintenance, and retention of all files (e.g., design history files, device history records, and other quality system records) per domestic and international regulatory requirements
• Responsible for understanding and ensuring compliance with all domestic and international medical device quality system regulations and standards, where appropriate
• Responsible for ensuring all document control processes are compliant with AtriCure quality system and company policies
• Provide training on how to utilize the document control system to new hires, transfers, co-ops, etc. This includes training on the various processes and systems used (e.g. MasterControl, DocuWare, filing, e-forms, signature cards, record retention, etc.)
• Provide support to users with timely responses to questions regarding Document Control processes
• Coordinate and manage the transfer of quality system records to and from the offsite storage facility, Iron Mountain. Identify and escalate issues
• Responsible for administering external standards management as assigned
• Serve as the MasterControl expert, proactively assessing and identifying new features or methods to enhance efficiency and compliance
• Collaborate with the organization to tailor or create solutions in MasterControl to meet evolving business needs and regulatory requirements.
• Responsible for administering electronic record storage including overseeing the processes and software (i.e. DocuWare)
• Assist in internal audits as assigned
• Support external audits as assigned
• Aid in finished product release activities as assigned

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

• Regular and predictable worksite attendance
• Ability to work under fast-paced conditions
• Ability to make decisions and use good judgement
• Ability to prioritize various duties and multitask as required
• Ability to delegate responsibilities to team members as appropriate
• Detail-oriented
• Good communication skills (both verbal and written)
• Ability to successfully work well with others
• Additional duties as assigned

BASIC QUALIFICATIONS:

• Bachelor’s degree or equivalent education, training, and experience
• Experience with document management software such as Master Control
• Proficient with Microsoft office software (Word, Excel, Outlook, PowerPoint)

PREFERRED QUALIFICATIONS:

• Supervisor experience
• Auditing Experience
• Experience in a regulated industry or familiarity with medical device regulations (21 CFR 820 and ISO 13485)
• Read blueprints, drawings, and specifications

OTHER REQUIREMENTS:

• Ability to regularly walk, sit, or stand as needed
• Ability to work at a computer for extended periods
• Ability to occasionally bend and push/pull as needed
• Ability to regularly lift up to 25 pounds
• Ability to travel up to 5%
• Ability to pass pre-employment drug screen and background check

#LI-AM1