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QA Manager - Maryland Heights

Company: Elekta
Location: Saint Charles
Posted on: August 16, 2019

Job Description:

Are you a current Elekta employee? Please click here to apply through our internal career site Find Jobs - Elekta.Want to join a team with a mission to improve and save lives? We continually look for motivated and skilled individuals who are interested in supporting our customers - healthcare professionals who use our products to help patients and their communities.

We currently have the following opportunity available - please contact us for more details!

Summary

The QA Manager oversees applicable quality processes to ensure safe and effective products and services. This position ensures the promotion of awareness of applicable regulatory and quality management system requirements throughout the organization and works closely with site, and functional teams in all areas in the organization to achieve results. The selected candidate manages individuals to meet quality and business objectives and champions quality culture and education at all functional levels in the organization, supports and fosters continuous quality improvements, and is a coach and mentor for quality related matters.

In certain geographies, when applicable, the Quality Manager ensures regulatory compliance of the relevant quality system and monitors process trends to identify compliance improvements of all related processes. The QA Manager may be assigned the deputy quality representative role.

The position is based in the office located in St. Charles, MO.

Responsibilities


  • Responsible for ensuring compliance to the quality management system as applicable.
  • May serve as quality management representative before regulatory authorities.
  • Ensure or assist in the timely execution of relevant quality and compliance activates such as management review, internal and supplier audits, change management reviews, CAPA board meetings, etc.
  • Collaborate closely and communicate effectively with other functional areas of the organization to meet business objectives ensuring regulatory compliance.
  • Ensure third party controls are maintained with regard to processes for controlling representatives and suppliers.
  • Ensure that the effect of any new or changed medical device regulations are incorporated into processes as necessary.
  • Represent the QA Group position on quality matters, as directed by Vice President Quality Assurance.
  • Ensure or assist in the monitoring and measuring of relevant processes (e.g. Design and Development, manufacturing, complaints, CAPA, etc.) and seek to improve practices based on internal and external trends and information.
  • Manage and develop staff capabilities (competencies, knowledge, skills and experience) within the function so as to meet the business needs and long-term development of the organization.
  • Ensure alignment of individual development and performance metrics with organizational objectives and establish and monitor for the individuals under their responsibility.
  • Manage departmental budgets as applicable.
  • Work on the execution, deployment or defining of the overall strategy for the Quality organization.
  • Ensure the Quality Policy and Quality Objectives are deployed and understood in the organization. Establish forums to promote quality culture and acts as a mentor to others regarding quality and compliance.
  • Train, and develop team members in their organization.

    We offer:

    • Excellent Medical, Dental, and Vision coverage
    • 401k, paid Vacation and Holiday
    • A wealth of additional benefits including Wellness Reimbursement, Tuition Reimbursement and Flexible Spending Account
    • Opportunity to work in the cutting edge in medical advancement
    • Close knit company culture
    • Upward mobility

      Requirements

      • Bachelor's degree in Engineering or equivalent or a related field.
      • Training and experience in relevant medical device regulatory requirements and standards. E.g. ISO, IEC, MDD, QSR, CMDR.
      • Proven skills in processes evaluation and development.
      • Strong experience in project management.
      • Experience in application of risk management controls.
      • Leadership, Coaching and Problem solving skills.
      • Strong written and verbal communication skills and ability to generate collaborative spirit.
      • Autonomous, detail oriented driven by results achievement.
      • Ability to work proactively to drive results.
      • Ability to work efficiently under tight timelines.
      • Proven fluency in English and other applicable languages relevant to their specific geographies.
      • Travel is required.
      • Quality professional certifications preferred (e.g. CQI, CQMoE, CQA, CQE).
      • Experience in quality improvement tools and techniques is a plus (e.g. Lean, Six Sigma, DOE, Statistical Methods, etc.)

        EEO Statement

        We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, disability, veteran status, or any other protected characteristic.

Keywords: Elekta, Saint Charles , QA Manager - Maryland Heights, Executive , Saint Charles, Missouri

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