Quality System Manager

Date: May 22, 2022

Location: St. Paul – Minnesota, US, 55127

Company: Heraeus

[title]
Quality System Manager
Location St. Paul – Minnesota
Permanent  
Full Time
 

Together we improve lives. At Heraeus Medical Components, we leverage our breadth of expertise in material science, leading-edge technologies, and supply chain excellence to build sustainable and successful partnerships with medical device OEMs. As a result, the work we do is felt and trusted by our partners and the patients who rely on them for life-saving and life-changing medical devices.

We are committed to the pursuit of doing things better because we know that today’s best is simply tomorrow’s building block for what’s next. As a global company with 10 locations and over 1,900 employees worldwide, backed by a Fortune 500 holding company that has been around for more than 200 years, we are committed to the growth of our teams and sites. Our vision is to improve 100 million lives each year, and to accomplish our vision, we have built a culture of curiosity that thrives on challenge, continuous learning, and the opportunity to take risks and try new things. Good ideas are celebrated here, so join us as we act boldly, think openly, work thoughtfully, and with our partners, improve patient lives worldwide.

 
 

The Following Challenges Await You:

  • Establishes Quality System objectives in alignment with organizational objectives and leads the team in the achievement of set objectives and goals. 
  • Provides guidance and training to staff, assists in attaining career goals, motivates individuals to achieve results, and recruits and maintains a high-quality team.
  • Communicates, explains, and assures that all departmental duties and responsibilities are carried out in a way that is supportive and consistent with global and site procedures, policies and strategic plans.
  • Determines appropriate staff levels and schedules. Works with key partners to understand priorities and plan resource allocation accordingly.
  • Ensures maintenance and implementation of requirements for quality processes.  Oversees quality management system processes such as supplier quality, CAPA, internal audits, calibration, document control and training.
  • Maintains and improves quality management system documentation, i.e. policies and procedures to ensure ongoing compliance with quality system standards and requirements as well as current company and industry practices.
  • Works collaboratively with functional business groups to drive continuous improvement in system integration, interfaces with business processes, and ensures effectiveness of quality management system is maintained.

 

Your Profile:

  • BS/BA degree preferred with a minimum of 7 years of related work experience including experience in a quality supervisory or management role required.  
  • Minimum 2 years supervisory or management experience preferred.  Experience with ISO 13485 and 21 CFR 820 standards and regulations, MDSAP desired.
  • Experience with MDSAP and regulatory body audits
  • Knowledgeable in CAPA system
  • Good understanding of training in a medical device manufacturing company

 

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Nearest Major Market: Minneapolis