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Quality Design Assurance Engineer

Date: Dec 1, 2021

Location: Fridley – Minnesota, US, 55421

Company: Heraeus

[title]
Quality Design Assurance Engineer
Location Fridley – 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 quality of 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 relentless in our 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 headquartered in the medical device hub of Minnesota, with 10 locations in the Americas, Europe, and Asia, two Collaboration Hubs dedicated to R&D, and 2,000 employees worldwide, we are committed to the growth of our teams and our organization. To help drive this growth, our company is backed by a Global Fortune 500 holding corporation that has been around for more than 200 years, with a history of providing open spaces for open minds.  Our vision is to improve 100 million lives each year. To accomplish our vision, we have built a culture of curiosity that thrives on challenge, continuous learning, and the opportunity for our people to advance and develop. 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:

• Represent Quality Assurance on product development teams, including developing Quality Plans and Risk Management Plans
• Support design and development project deliverables related to Design Controls, Risk Management, Design Verification and Validation to ensure meet applicable standards

  and regulatory requirements while ensuring a primary focus on patient safety and reliable product performance
• Design and/or specify inspection and testing procedures/systems to ensure products conform to specifications and quality standards
• Investigate/analyze customer complaints and support Regulatory Affairs to monitor customer complaint trends and maintain compliance to complaint system
• Support all functional departments to ensure compliance with Quality System and lead continuous improvement efforts of the Quality System.

 

Your Profile:

• Bachelor's Degree in Engineering or related field required.
• A minimum of 5 years related engineering work experience. 
• Experience is in the medical device industry as a Design Quality Assurance Engineer strongly preferred.

• Practical experience/familiarity with ISO 13485, FDA Quality System Regulations, Good Manufacturing Practices, Good Laboratory Practices, ISO 14971 and other applicable standards.
• Must be highly organized and can manage multiple projects concurrently.
• Must possess practical knowledge related to products that the position will support.
• Must possess good written and verbal communication skills as well as team building skills, basic PC skills, and have working knowledge of Microsoft Word, Excel, and Minitab.

 


Nearest Major Market: Minneapolis