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Quality Systems Manager

Date: Jul 27, 2019

Location: St. Paul – Minnesota, US, 55127

Company: Heraeus

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

A globally leading technology group, Heraeus is headquartered in Hanau, Germany. Founded in 1851, it is a family-owned portfolio company which traces its roots back to a pharmacy opened by the family in 1660. Today, Heraeus combines businesses in the environmental, energy, electronics, health, mobility and industrial applications sectors. In the 2017 financial year, the FORTUNE Global 500-listed company generated a total revenue of €21.8 billion. Our promise to about 13,000 employees is to enable them to develop their own ideas and to drive them forward.

 

Your Role & Responsibilities:

  • Ensure maintenance and implementation of requirements for quality processes.  Oversee quality management system processes such as CAPA, internal audits, document control and training.
  • Maintain and improve 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.
  • Serves as a key quality systems subject matter expert to the organization. Participates in organizational training to drive organizational competency in quality management system requirements.
  • Lead Supplier Quality engineering in day to day oversight of product and service providers ensuring sustaining supplier quality management activities i.e. new supplier selection, approval, change control process, supplier SCAR, CAPAs, supplier performance measurement and oversight & trending including audits.
  • Manage the implementation of the supplier change notifications and ensure appropriate oversight of supplier change process that assures all qualification and validation activities are meeting pre-defined product and process specifications.
  • Manage external supplier audits program and ensure execution of audits per audit program requirements.

 

What is required for this role:

  • Experience with ISO 13485:2016 and quality system processes including training, CAPA and Document Control.
  • BS/BA Degree preferred with a minimum of 4 years experience in a management role with solid developed leadership skills. 
  • Subject matter expert on supplier control requirements and processes. 
  • Experience in establishing an effective supplier control system.
  • Experience in developing a strong and sustainable training program.
  • Experience and knowledge in continuous improvement preferred.

 


Nearest Major Market: Minneapolis