Document Control & Training Manager

About Avive:

Avive Solutions, Inc. (https://avive.life) is a VC-backed healthcare technology company that is developing a next-generation Automated External Defibrillator (AED) and response system in an effort to – literally – save lives. Sudden Cardiac Arrest (SCA) is a leading cause of death in the United States, and we are on a mission to change that! We are a dynamic team that builds elegant, creative solutions to solve complex problems. Ultimately, our mission is for all cardiac arrest victims to have rapid access to life-saving defibrillation.

Avive is taking a fresh approach to addressing this decades-old problem by working to bring an advanced AED technology to market, coupled with a first-of-its-kind software platform solution to enable a quicker and more streamlined response to cardiac arrest emergencies. We believe that this unique combination of deploying advanced – yet still accessible – hardware, and novel software, has the potential to revolutionize out-of-hospital cardiac arrest response and massively impact SCA survival rates.

Check out this short video that shows a glimpse of how our team is working to re-think cardiac arrest response and save lives! https://www.youtube.com/watch?v=2p4zfOWo62E

Learn more about working at Avive: https://avive.life/careers/

About the Role:

The Document Control & Training Manager is responsible for managing and maintaining all aspects of the Avive’s Document Control and Training programs to ensure compliance with FDA QSR (21 CFR 820), ISO 134854, and other applicable national and international regulatory and quality requirements.  As an integral member of the Quality team, this position is responsible for ensuring that quality systems elements are implemented, compliant, effective and efficient for meeting the needs of the Company, including development, documentation, implementation and maintenance of quality systems requirements.  This position requires excellent organizational skills, interpersonal skills, communications skills, and the ability to perform at a high level in a fast-paced and dynamic environment. 

• Document Control / Quality Records
• Manage and maintain the Document Control System and Quality Records Program with an emphasis on continuous improvement, systems effectiveness, efficiency and compliance to meet regulatory requirements, and current and future business needs. 
• Manage the Company’s controlled documents and quality records, including external reference standards/documents, to ensure security, accuracy and accessibility of controlled documents and quality records both internally and externally. 
• Manage the release process of new and revised controlled documents, including collaborating with other functions to develop and implement release processes, perform Document Change Order (DCO) reviews, and making documents available within an electronics Quality Management System (eQMS).
• Ensure the Company’s eQMS operates effectively and efficiently to meet the needs of internal customers, business objectives/needs, and Company quality objectives.
• Ensure document control processes and procedures are compliant with regulations and that department procedures are current and adequate to meet applicable regulations.
• Ensure the on-going effectiveness and compliance of the eQMS as it relates to DCOs, document management, and training processes. 
• Collaborate with change order initiators on processing DCOs.
• Ensure complete and timely DCO processing including pre-DCO review, approval, release and implementation. 
• Ensure complete and timely distribution and retrieval of hard copy controlled documents to prevent inadvertent use of obsolete, superseded, and down-revision documents.  
• Manage electronic files of controlled documents in a secure manner to prevent unauthorized changes and coordinate back-ups of electronic files to ensure recovery in the event of lost data.
• Work with and provide controlled document to Suppliers and Contract Manufacturers as appropriate/necessary in coordination with Ops, R&D and Supplier Quality as applicable.
• Measure, monitor, and report on Document Control metrics to ensure system effectiveness, efficiency, and implementation of updates/changes as necessary.  

• Training Program
• Oversee and maintain the Training Program with an emphasis on continuous improvement and system effectiveness and efficiency to meet regulatory requirements, and current and future business needs.
• Maintain training files and ensure that each employee has a current Training Plan, and that Training Records are complete and current.
• Manage, maintain and monitor Company training records (employe and consultant) in the eQMS and/or hard files as applicable.
• Collaborate with department managers to ensure appropriate Training Plans are prepared for all new hires and updated as necessary for current employees.  
• Monitor the Company’s eQMS to ensure that training and retraining on all required procedures and latest revisions are performed, including instructor lead training sessions.  
• Measure, monitor and report on Training metrics to ensure system effectiveness and efficiency, and implement updates/changes as necessary to meet changing business needs.

• External Standards Maintenance
• Ensure external standards are maintained, current, accessible, and available for use.•Partner with service providers on external document change notifications and the purchasing of new and revised standards as applicable.
• Partner with service providers on external document change notifications and the purchasing of new and revised standards as applicable.Ensure gap assessments are performed for applicable revised/updated externals standards by appropriate Company personnel.

• Other Duties
• Establish and maintain Standard Operating Procedures (SOPs), Work Instructions, and Form related to areas of responsibility.
• Advise, train, and support Company personnel in best practices, processes and approaches concerning areas of responsibility, including Document Control and Training system requirements and workflows.    
• Partner with cross-functional teams to develop, validate, and implement additional eQMS modules that are aligned with the Company’s growing business needs.
• Coordinate product information language translation with outside services as need
• Participate in Management Review meetings and assist in gathering, preparing, analyzing and presenting data to Executive Management on the performance of the Quality Management System for areas of responsibilities.  
• Interact and interface with various government agencies, private companies, and consultant (such as CA FDB, US FDA, Notified Bodies, external consultants), related to quality system audits/inspections and assist in timely responses to any findings. 
• Develop, establish, monitor, and report on both corporate and departmental quality objectives, metrics, and goals.

• At least 5 years of experience in Document Control and/or Quality Systems in the medical device industry.
• BS or BA degree or related practical experience preferred.
• Exceptional knowledge of national and international quality systems requirements (e.g. FDA QSR, ISO 13485, MDR, etc.) and related EN/ISO standards.
• Experience with using, administering, validating, implementing, and maintaining electronic Quality Management Systems (eQMS).
• Strong written, oral, interpersonal skills, analytical skills, and problem-solving techniques.
• Excellent level of organizational skills and ability to work and drive multiple projects at the same time with high level of attention to detail.
• Strategic yet hands-on when needed, high degree of energy and drive, and the ability to continually seek to make improvements to the functions, processes and people being managed.
• Open and direct communication style and a vision for continuous improvement and operational excellence.
• Ability to travel up to 10% as needed to support business needs, professional networking, and on-going development. 
• Experience with Class III medical devices.
• Experiences in reading and interpreting engineering drawings, specifications, and statistics.
• Experience using internet cloud storage services and Adobe Acrobat document management software.

Equal Employment Opportunity

It is the policy of the company to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, the company will provide reasonable accommodations for qualified individuals with disabilities.

NOTE: This Job Description in no way states or implies that these are the only duties or functions to be performed by the incumbent. Personnel are required to follow any other job-related instructions and to perform any other job-related duties/functions requested by their supervisor.

Anticipated salary range: $110,000 - $130,000

Salary : $110,000 - $130,000