QA Manager - Maryland Heights
Location: Saint Charles
Posted on: August 16, 2019
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products to help patients and their communities.
We currently have the following opportunity available - please
contact us for more details!
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.
- Responsible for ensuring compliance to the quality management
system as applicable.
- May serve as quality management representative before
- 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,
- 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
- Train, and develop team members in their organization.
- Excellent Medical, Dental, and Vision coverage
- 401k, paid Vacation and Holiday
- A wealth of additional benefits including Wellness
Reimbursement, Tuition Reimbursement and Flexible Spending
- Opportunity to work in the cutting edge in medical
- Close knit company culture
- Upward mobility
- Bachelor's degree in Engineering or equivalent or a related
- 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,
- Experience in quality improvement tools and techniques is a
plus (e.g. Lean, Six Sigma, DOE, Statistical Methods, etc.)
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
Keywords: Elekta, Saint Charles , QA Manager - Maryland Heights, Executive , Saint Charles, Missouri
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