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Global Quality Manager

Date: Oct 1, 2021

Location: St. Paul – Minnesota, US, 55127

Company: Heraeus

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

Imagine a job where you will have the opportunity to do exciting and challenging work, while collaborating with extraordinary colleagues. A company that invests in you and your career, providing the training, mentoring, development and support you need to be successful now and in the future. If you want a career without limits with a market-leading family-owned, global company where you can make an impact, then imagine an opportunity at Heraeus. Every day, our worldwide team of around 14,800 employees are bringing forward new ideas and solutions that are impacting and transforming everything from healthcare to renewable energy to e-mobility to high-tech and telecommunications.

 
 

The following challenges await you:

  • The primary responsibility of this position is to support the Global Quality Director in developing and implementing Global Quality standards and manage activities related to the Global Quality system and programs.  
  • This role will implement, maintain, and improve HMCs quality organization, systems, and overall processes to ensure high quality products are delivered to our customers. T
  • The Global Quality Manager will support the implementation of standards, methods, metrics, and procedures for inspecting, testing, and the reliability of company products.  This includes the use of six sigma and other methodologies to improve performance by systematically removing waste and reducing variation.
  • the position requires direct customer interaction at our HMC locations as well as customer sites worldwide.
  • You will have leadership responsibility along with the Site Quality leaders.

 

Your Profile:

  • Bachelors or Masters Degree in Engineering or related scientific discipline.  

  • 10+ years of experience in quality assurance and/or Engineering in manufacturing positions in the medical manufacturing industry.  

  • Accomplished manager of technical resources with a proven record in building and motivating successful Quality Assurance efforts.  

  • Minimum of five years in a quality leadership role in a medical manufacturing environment.

  • Knowledge of regulatory requirements and their interpretation such as current Good Manufacturing Practices and regulations/standards including, but not limited to:
    • BS EN ISO 13485:2016 Medical devices
    • BS EN ISO 9001:2015
    • ISO 14971:2019 Medical devices  
    • 21 CFR 820, 11, 801, 7, 803, 806, 802, 821, 822
    • EU Medical Devices Regulation April 2017 (EU MDR)
    • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (EU MDD)
    • Health Canada SOR 98-282 (Health Canada)
    • Australian TGA - Therapeutic Goods (Medical Device s) Regulations 2002 (TGR)
    • Brazilian Health Surveillance Agency, Resolution RDC 16 2013, RDC 23 2012, RDC 67 2009 (RDC)
    • Japanese Medical Device QMS Requirements and other related Regulatory Info


Nearest Major Market: Minneapolis