Manager of Quality Engineering

Company: AtriCure
Location: Mason
Posted on: January 16, 2022

Job Description:

AtriCure, Inc. provides innovative technologies for the treatment of 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 medical device to receive FDA approval for the treatment of persistent Afib. AtriCure's AtriClip - Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure's Hybrid AF--- Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure's cryoICE cryoSPHERE - probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

POSITION SUMMARY:
This position will be responsible for management of the quality engineering group and processes that affect technical product quality and impact the state and control of finished product in compliance with global regulatory requirements (ISO, FDA, MDD, MDR, etc.).The Manager, Quality Engineering is responsible for ensuring production and process controls are consistently within a state of control ensuring effective risk mitigations are put in place.Responsibilities include setting direction, planning, coordination, and timely completion of day-to-day activities.
The primary activities will be in support of internal manufacturing quality which includes selection of inspection and verification methods, process validation, product non-conformances, investigations, and corrective actions.Secondary activities will be in support of supplier quality, product development, sustaining engineering, and manufacturing engineering.

ESSENTIAL FUNCTIONS OF THE POSITION:

• Manage Operations activities by providing quality leadership and direction to quality engineering team to ensure company objectives are met in a timely manner.
• Manage the tactical execution of short- and long-term quality engineering and production and process control objectives through the coordination of activities with a direct responsibility for results, including costs, methods, and staffing. Coordinates and manages the efforts of multiple staff levels and disciplines/specialties within quality engineering.
• Leads and models the need for interpersonal and cross functional coordination, and initiates company-wide cooperative actions to ensure effectiveness of quality engineering and production and process controls.
• Provides oversight responsibility for the NCR system including managing day to day execution of the process as well as the review and improvement of the NCR process itself.
• Provide leadership, mentoring, and development plans for all direct reports to maintain an engaged and productive workforce. Manages and mentors employees in department to ensure initiatives and objectives are obtained; seeks feedback to identify improvement activities and acknowledges others efforts and accomplishments.
• Technically proficient in quality engineering. Utilizes proven techniques and knowledge of functional area to significantly contribute at the individual contributor and manager level. Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current trends.
• Establishes operational objectives and applies knowledge and medical device and quality engineering best practices to achieve operational results.
• Assure the development, establishment, validation, and implementation of production and process controls. Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals.
• Create reports for quality records, oversees the creation of inspection records, specifications and other reports and communications. Ensure data accuracy and integrity with appropriate techniques, supervise root cause analysis methods and corrective action investigations.
• Follow processes and operational policies in selecting methods and techniques for obtaining solutions. Interprets and recommends change to policies and establishes procedures that effect immediate organization(s).
• Frequently interacts with direct reports and functional peer group managers, normally involving matters between functional areas and/or other departments. Develops and maintains effective relationships through effective and timely communication.
• Participate and presents at meetings with internal and external representatives. Often leading a cooperative effort among members of a project team.
• Interact with internal departments and external customers, particularly in problem resolution. Acts as an advisor to subordinate(s) to meet schedules and/or resolve technical problems .Provide input for hiring, mentoring, and counseling employees, including performance reviews and disciplinary action as needed.
• Apply reason and organization to prioritize projects, adapt to shifting priorities, work with minimal supervision, negotiate, and problem solve
• Operate with appreciable latitude for actions and/or decisions on day-to-day activities. Receive or seek guidance on novel or controversial problems that may impact the business significantly
• Compose and present summary reports to management summarizing activities, including trending and graphic representations.
• Support and/or perform external/internal audits as necessary
• Assist with various projects as assignedADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
  
  • Regular and predictable worksite attendance
  • Ability to work under fast-paced conditions
  • Ability to make decisions and use good judgment
  • Ability to prioritize various duties and multitask as required
  • Ability to successfully work with others
  • Additional duties as assignedBASIC QUALIFICATIONS:
    
    • Bachelor's degree required or demonstrated equivalent combination of education, training and experience
    • Minimum 6 - 8 years' experience in product development and manufacturing.
    • 3+ years' supervisory or project/program management experience preferred
    • Knowledge of FDA regulatory requirements (cGMP/QSR) required.
    • Knowledge of ISO 13485 is required.
    • Experience planning and implementing manufacturing process controls such as inspection, testing, and measurement processes is required.
    • Knowledge of Process Validation and Test Method Validation required.
    • Knowledge of Quality practices (such as Failure Modes Effect Analysis (FMEA), and Root Cause Analysis) required.
    • Ability to effectively work cross-functionally with R&D, Manufacturing Engineering, Supply Chain, Operations, Regulatory, and Marketing.
    • Strong problem solving and technical skills.
    • Strong oral and written communication skills.
    • Must be a team player, positive, energetic, and an advocate for product quality and excellence
    • Candidate must be results oriented, quick learner, respond to the urgent needs of the team and show a strong track record of meeting deadlines.
    • Ability to travel 15%PREFERRED QUALIFICATIONS:
      
      • Medical device manufacturing experience strongly preferred
      • Experience with single use, sterile, packaged medical devices strongly preferred
      • ASQ certification (e.g. CQE, CQA, CQM/OE, CSSBB, etc.)
      • Preferred knowledge of appropriate external standards (e.g. IEC 60601-1, IEC 62366, IEC 62304, etc.) projects.OTHER REQUIREMENTS:
        
        • Ability to regularly walk, sit, or stand as required
        • 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#LI-KN1
          
          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 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 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).

Keywords: AtriCure, Cincinnati , Manager of Quality Engineering, Executive , Mason, Ohio