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Senior Design Assurance Engineer - Medical Device

Job Ref No: 
1248625
Location (Region): 
Location: 
Milford
Subsector: 
Job group: 
Quality regulatory affairs
Contract/Perm: 
Contract
Consultant: 
broadbean
Consultant name: 
Daniel Ferzoco
Phone Number: 
+1 617-428-3685
Local Salary: 
US$100000 - US$125000 per year
Intro: 

This position will be responsible for leading quality engineering activities associated with new product development, quality systems and risk management on several products and systems.

Job Description: 

The candidate's primary responsibility will be to handle quality engineering duties in the following areas: design controls, risk management, change control, post market review, quality planning, and establishment of appropriate requirements management and traceability.

Who we're looking for: 

The candidate's primary responsibility will be to handle quality engineering duties in the following areas: design controls, risk management, change control, post market review, quality planning, and establishment of appropriate requirements management and traceability.

* Participate in new product development projects by providing quality engineering services to assigned projects. Ensure defendable engineering and scientific analyses are employed and design history files comply with company policies and governmental regulations.
* Key deliverables including, but not limited to product performance analysis on similar products, risk management, essential requirements checklist, design verification / validation, design transfer to manufacturing, documentation completion tracking, and product release authorization for distribution of product.

About our client: 

Our latest client is a publicly held IVD and medical device manufacturer based in the Worcester County area. This company's revenue grown to $2 billion within the last year. Its products consist of electrical, mechanical, and software components. They offer just under a dozen products with hundreds of customizations for each product.

What's On Offer: 

* Strong base salary
* Relocation package is offered for qualified candidates
* Completely new department. The Design Quality Engineering department has only launched in 2015. This position will help drive a new organizational structure.
* Competitive benefits package
* Highly rated company to work for
* Ample opportunity for promotions
* Market leader for company's product range

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