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Quality Manager, Design Assurance

Date: Sep 8, 2021

Location: Fridley – Minnesota, US, 55127

Company: Heraeus

[title]
Quality Manager, Design Assurance
Location Fridley – 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.

 
 

Your Role and Responsibilities

  • Leads team in the achievement of quality and organizational 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.
  • Manages resource allocation in support of development projects.  Works with key partners to understand priorities and plan resource allocation accordingly.
  • Leads quality team on product development projects of major magnitude, complexity, and scope.
  • Ensures requirements related to Design Controls, Risk Management, Product Performance, Quality and Compliance are executed to provide a high standard of product quality that conforms to global standards and regulatory requirements while ensuring a primary focus on patient safety and reliable product performance.
  • Provides quality resources required for test method development and validation, product verification and validation activities, coordination of reliability testing associated with new product development, evaluation of data for statistical validity, component qualifications, process capability studies, equipment qualifications, and process validations.

 

What is Required for This Role

  • BS/BA degree in Engineering or other technical discipline preferred and a minimum of 2 years equivalent work experience in a supervisory or management role and/or 7+ years in QE/QE supervisor role required.
  • Medical device manufacturing, EN ISO 13485, MDSAP and FDA QSR experience strongly preferred. 
  • Demonstrated experience with design controls, statistical analysis, root cause analysis, FMEA, project management, SPC, Six Sigma Tools and Geometric Dimensioning and Tolerancing.


Nearest Major Market: Minneapolis