Who is Ultivue?
Ultivue is a venture-backed company based in Cambridge, MA, developing reagent-driven solutions for high-performance biological imaging in tissue samples. Our proprietary solutions enable translational and clinical research groups to realize the promise of personalized medicine through the deciphering of complex mechanisms of cancer onset and progression as well as the identification of biomarker signatures in tumor tissue samples to better match patients to therapeutic options. Ultivue develops and commercializes products and services that seamlessly integrate into existing laboratory workflows to support biomarker discovery, assay validation, and potential companion diagnostic applications.
What's in it for YOU?
Ultivue is a growing start up, executing novel research and development, and already generating revenue with our commercial line of products. Get in at the ground level and make an immediate and lasting impact on Ultivue's mission. In addition, take advantage of our industry-competitive benefits package focused around three core objectives: supporting health, financial security, and fun. Our comprehensive benefits plan provides a wide range of options for everyone's needs including health plans, wellness options, and financial support, in addition to unlimited vacation! At Ultivue the pace is fast, the people are passionate, and engagement is high. If you would thrive by rolling up your sleeves while also being strategic and autonomous, where you will be rewarded for your efforts and productivity, then you'll fit in beautifully here. We love what we do!
The Associate Quality Engineer will support the quality assurance department, promoting product quality and quality system compliance consistent with Ultivue's company goals including the direction, planning and execution of quality improvement initiatives. The Associate Quality Engineer will report into the Senior Director of Quality & Regulatory.
How You'll Contribute:
- Conducts and supports investigations of manufacturing nonconformities; recommends, develops and implements effective corrective actions
- Coordinates, collects, analyzes and distributes quality monthly and quarterly metrics
- Participates in audits conducted by regulatory agencies and/or customers
- Participates in supplier evaluation and selection assessments
- Ensures appropriate compliance and operational effectiveness in all areas of the QMS including document control, change control, training, complaint handling, CAPA, nonconforming process and auditing (internal and external)
- Works in collaboration with Product Development to ensure that the designs, procedures and outcomes of the project are acceptable in quality.
How You'll Succeed:
- Minimum of 5 years of overall QA experience in an ISO and FDA regulated environment, with at least 3 years in a direct Quality role is required
- College degree is preferred but not required
- Experience with ISO 13485 certification and FDA's 21CFR 820 is required
- Experience in a Good Manufacturing Practice (GMP) environment is required
- Extensive experience writing and implementing policies, processes and procedures is required
- ASQ certified Quality Auditor and/or Quality Engineer is preferred but not required
- CQE, CRE, PE, CRA and/or Lean Six Sigma Certifications are highly desirable
- CLIA experience is a plus
- LIMS experience is a plus
- Invitro Diagnostics (IVD) experience is a plus