Quality Engineer

About the role:

Elemental Machines is seeking an experienced and organized full‑time Quality Engineer to join our team in the development of industry‑leading IoT devices and sensors. In this position, you will support the tactical processes used by EM to ensure our development and product fulfillment processes are ISO
9001‑compliant and continuously meet business objectives, and will contribute to the improvement of current systems and support internal and external audits.

Boston‑based, on‑site role. Reporting to the Quality Manager.

• Conduct time‑sensitive activities to support our quality system, such as execution and management of Change Orders, set up of product information in ERP and QMS systems, creation of supporting product documentation, coordination and support of gauge calibration with external calibration houses, and other reporting requirements to ensure compliance to ISO 9001.
• Support Engineering and other internal teams by executing procedures for receiving inspection and lot acceptance.
• Perform processing of root cause analysis and corrective action procedures to ensure timely review of non‑conforming products.
• Collaborate with each department to ensure training records for EM staff are up‑to‑date.
• Support the development of testing programs by documenting the results of test protocols and communicating the results of process capability studies.
• Ensure documentation of all product components, assemblies, and finished goods meet internal requirements.
• Participate in project meetings for the development of new products/services with internal engineering teams and contract manufacturers, as needed.
• Support the generation of compliance and regulatory documentation related to new product launches.

• Bachelor’s degree in an Engineering discipline, or equivalent technical background.
• 0‑2 years of experience working in an ISO‑regulated environment, such as ISO 9001 or ISO 13485.
• Basic knowledge or experience of working with electronic‑based products.
• Experience in using electronic platforms for Quality Management Systems.
• Familiarity with Agile‑based project management tools.
• Proficiency in MS Office products.
• Excellent verbal and written communication skills.
• Ability to lift 50 pounds, unassisted.

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 Lab Ops teams in charge of machines, instruments, data, facilities, training, quality, and compliance to lead data‑driven discovery, development, and delivery. But there are over 300 million physical instruments, devices, and machines not yet connected to the cloud.

We are simplifying the connection between the physical and digital worlds using IoT and AI‑driven insights. The result is a lab united by a universal cloud‑connected dashboard and operations. Elemental Machines is on a mission to enable intelligent operations by connecting the physical and digital infrastructure to optimize outcomes. Science and technology leaders trust Elemental Machines’ ecosystem of hardware and software to deliver actionable insights that accelerate their pace of innovation.

We enable data‑driven discovery, development, and delivery within organizations ranging from biopharma labs to biobanks, analytical labs, and manufacturers in the life sciences and beyond.