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Quality Engineer

  • Anywhere

Company :
CareCubes

Location :
Minneapolis, Minnesota

Expiry Date :
Fri, 16 Apr 2021 23:59:59 GMT

Apply Job :
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Description :
CareCubes is a late-stage start-up company creating the future in negative pressure isolation units. We are hiring a talented Quality Engineer professional who can work with the Quality Director to set up and operate a quality system from the ground up to scale with us as we commercialize the CareCube Patient Isolation System.

ESSENTIAL DUTIES AND RESPONSIBILITIES

* Set up and develop the quality systems and sub-systems to support the development and operations activities.
* Oversee production to ensure conformity through final assembly both internally and externally.
* Develop a robust relationship with our supply base to assure compliance and quality standards are met and traceability is fully operationalized
* Participate in new product development teams to assure GDP guidelines are met to assure the DHF is suitable to support global regulatory filings.
* Make crucial decisions in favor of cost-efficiency without compromising on quality
* Identify and implement quality control processes to ensure quality criteria are always met
* Execute tests to assure final product adherence to all criteria and applicable standards
* Develop KPIs and collaborate with operations to identify and address areas of concern
* Brainstorm ideas to increase productivity and performance of the production line while maintaining accuracy in quality

Requirements
* 4+ years of full-time work experience is desired in quality-related roles with an emphasis on quality systems
* Recent experience in the biotechnology, medical, or medical device industries is preferred
* Prior experience as a quality engineer in the medical device field.
* Experience in CAPA, Supplier Quality desired.
* Familiarity with GDP, GMP, and other FDA quality standards and processes
* Proficient in computer technology and manufacturing/quality systems
* Good understanding of Microsoft Office applications
* Strong leadership and management skills
* Self-motivated individual who works well independently
* Excellent analytical and problem-solving abilities
* Able to positively influence others
* Team player with strong interpersonal skills

EDUCATION

A minimum of a Bachelors degree in a technical field is highly desired although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field.

_The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required of personnel so classified._

Benefits

We offer an inclusive working atmosphere where ideas are respected and developed. Below is a list of our company perks.

* Competitive health, dental, and vision benefits
* Paid time off