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Quality Engineer

Quality Engineer

About the role:

Elemental Machines is looking for a full time Quality Engineer to join our Ops team in the development of industry leading IoT devices and sensors.  In this role, you will apply GxP principles to create new processes, improve current systems, and support product development of new products within an ISO 9001 regulated environment. 

Location:  Boston-based, hybrid role.  

 

Responsibilities:

  • Conduct time-sensitive activities to support quality system, such as Data security & Internal audits, Change orders, and other reporting requirements to ensure compliance to ISO 9001
  • Support engineering and operations by creating systems for receiving inspection and lot acceptance.
  • Lead activities related to root cause analysis and corrective action implementation for product and systemic non-conformances and system breakdowns
  • Collaborate with engineering to ensure training programs are robust and ensure training records for EM staff are up-to-date.
  • Support engineering development of testing programs by documenting test methods, acceptance criteria, and process capability studies.
  • Improve current systems for supplier controls and monitoring
  • Ensure specifications of all product component and assemblies are robust and meet internal requirements
  • Participate in project meetings with internal engineering teams and contract manufacturers as needed
  • Support the generation of compliance documentation related to product testing

 

Requirements:

  • Bachelor’s degree in an Engineering discipline
  • 3+ years of experience as a quality engineer, with a history of working with electronic-based products
  • Experience working in an ISO-regulated environment, such as ISO 9001 or ISO 13485
  • Experience in supporting the transition of products from development to production
  • Experience in using electronic Quality Management Systems
  • Familiarity with Agile-based project management tools
  • Formal training as a lead internal auditor
  • Excellent verbal and written communication skills

 

About us:

Today’s research, clinical, and quality control labs are expected to discover and produce at a pace once considered unimaginable. Now, to lead is to be led by data. The Elemental Machines platform elevates LabOps teams to lead data-driven discovery, development, and delivery by simplifying the connection between physical and digital worlds. The result is a lab united by a universal cloud-connected dashboard and operations, informed by monitoring of every asset and environment, both in real-time and over time.  Why? The standards established by operations determine the pace of output and discovery organization-wide.

 

The Culture:

Elemental Machines is a startup company based in Cambridge, MA, and we love it here! Being right next to some of the most innovative companies in the IoT and BioTech industries gives us drive and passion to pursue our own big goals, while enabling other companies to pursue theirs. 

We are committed to delivering on our promise to our customers: accelerate how they get science done. This commitment touches every level of our culture, because we are excited every day to stretch our creativity in balancing the needs of our customers with the resources at our disposal, and to thoughtfully interact with our peers to keep our mission on track.

 

Excellence in LabOps is a connection away.

What do we do?

We elevate LabOps teams to lead data-driven discovery, development, and delivery.

How do we do it?

We simplify the connection between the physical and digital worlds.

Why do we do it?

Optimizing the operations of research, clinical, and quality control labs has an exponential impact.

 

To Apply:

Please send your cover letter & resume to joinus@elementalmachines.com and be sure to put the job title you are applying for in the subject line. 

 

Also, please answer the following two questions in your email:

  1. Are you legally authorized to work in the United States?
  2. Will you now, or in the future, require sponsorship for Employment VISA Status (e.g. - H-1B VISA Status)?

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