Mid-level industry position
AtriCure, Inc. provides innovative technologies for the treatment of Atrial Fibrillation (Afib) and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure’s Isolator® Synergy™ Ablation System is the first and only medical device to receive FDA approval for the treatment of long standing persistent Afib. Additionally, our AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely used LAA management devices worldwide. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.
This position will be responsible for the development, implementation, and management of the corporate Quality training program. This role will also be the system administrator for the training software or system used. The Quality Specialist will proactively work with HR and other departments to ensure timely assignment of required training for new roles, transfers, etc. and maintain the corporate training matrix accordingly. They will assist in the establishment and support of the corporate training program for non-production employees. This position will also lead internal audits and conduct and coordinate audits for all AtriCure sites. In this role, this person will work with various departments throughout the organization to ensure compliance with AtriCure’s Quality System and will be responsible to report to management issues revolving around quality system compliance.
ESSENTIAL FUNCTIONS OF THE POSITION:
- Work cross-functionally to determine necessary training for functions/roles and assist in the development of the corporate training matrix
- Maintain training matrix and update as needed
- Train and provide guidance to managers on how to utilize training matrix
- Identify and make recommendations for improvements to training, job codes, program oversight, system, etc.
- Present recommendations and/or updates to leadership as needed
- Responsible for managing and assigning the appropriate training to employees (new hires, transfers, co-ops, etc.) within the designated training system
- Collaborate and provide support to the Operations and Compliance Training Coordinator to ensure appropriate training assigned to production associates
- Administrating the training software, including removing access/deactivating users in the training system for employees, contractors, and co-ops that leave the company
- Evaluate the creation and consolidation of job codes to best meet the needs of the user and/or department
- Identify and facilitate the resolution of any training discrepancies or issues (escalate as necessary)
- Review document changes via DCNs for required training and respond accordingly
- Coordinate the creation and issuance of usernames and accounts in the training system
- Review and monitor overdue training report and notify individuals that are not compliant (escalate as necessary)
- Track and trend metrics related to training as required.
- Provide training reports for users upon request and during audits
- Identify and document employees on leave of absence to suspend training assignments
- Lead, schedule, and conduct internal audits
- Summarize and present internal audit observations to leadership
- Draft and issue internal audit reports and maintain within the training system
- Ensure that all training and internal audit processes are compliant to AtriCure Quality System and Company Policies
- Identify and implement process improvements to the training and internal audit program when possible.
- Responsible for understanding and upholding domestic and international medical device quality system regulations, where appropriate
- Perform Quality System activities and other projects in addition to the above as needed
- Regular and predictable worksite attendance
- Strong organizational skills
- Ability to work under fast-paced conditions
- Ability to communicate effectively (both verbal and written)
- Ability to make decisions and use good judgment
- Ability to prioritize various duties and multitask as required
- Ability to collaborate and work successfully with others
- Additional duties as assigned
- Associates Degree in relevant major
- Experience with training coordination or training programs
- Experience with Quality Systems
- Strong computer/data entry and communication skills with an emphasis on attention to details
- Knowledge of quality improvement principles and project management, including formal training or certification and proven experience leading relevant business process improvement projects and/or quality improvement projects or teams
- Ability to travel 5%
- Auditing Experience or ISO 13485 lead auditor certification
- Ability to read technical Specifications
- Experience in MasterControl software
- Ability to occasionally bend and push/pull
- Ability to regularly lift up to 25 pounds, occasionally lift over 25 pounds
- Ability to pass pre-employment drug screen and background check
AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).
AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here https://www.e-verify.gov/
AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 15 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website: https://www.atricure.com/benefits
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to AtriCure must have a current Agreement in place, executed by a member of the Human Resource/Recruiting Department. In addition agencies may only submit candidates to positions for which they have been invited to do so by one of our Recruiters or Recruiting Managers. All unsolicited resumes sent to us will be considered property of AtriCure and AtriCure will not be held liable to pay a placement fee.
Are you a returning applicant?