Apply on Employer Site

HepQuant, LLC · 3 weeks ago

Quality Engineer I

Denver, CO

Full-time

Onsite

New Grad, Entry Level

$60K/yr - $80K/yr

0+ years exp

HepQuant is a clinical laboratory focused on developing blood-based quantitative tests for liver health. The Quality Engineer I will be responsible for providing quality assurance and engineering support for In-Vitro Diagnostics, maintaining the Quality Management System, and ensuring compliance with regulatory standards.

BiotechnologyHealth CareHealth DiagnosticsLife Science

Responsibilities

Ensure adherence to internal standards and compliance with formal external quality standards, such as ISO 14971 & ISO 13485

Identify and document potential nonconformities and perform root cause analysis for quality failures to implement corrective actions

Collaborates with cross-functional teams to identify and mitigate quality risks

Adherence to change management while providing revisions and updates to quality procedures & standardized work instructions

Initiate supplier qualification activities and evaluate supplier performance

Conduct audits of production processes and ensure compliance with regulatory standards

Assist with design development and transfer to manufacturing, including quality control activities from production processes to the shipment of final product

Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment

Review and approve product device history records

Qualification

Quality Management SystemFDA complianceISO 13485Statistical softwareMicrosoft Office SuiteAnalytical abilityProblem-solvingCommunication skills

Required

Bachelor's degree in an engineering discipline (Chemical, Mechanical, Biomedical, etc.) and 0-2 years in medical device, pharmaceutical, or biomedical, manufacturing experience or

2-4 years in a technical role in medical device, pharmaceutical, or biomedical manufacturing; with industry specific certification. i.e. ASQ CQE, SSGB, IVDR Compliance expert

Strong problem-solving and analytical ability and demonstrated ability for critical thinking, problem solving and innovation

Advanced experience with Microsoft Office Suite and Grand Avenue Software

Proficiency with statistical software such as MATLAB, Minitab, etc

Preferred

Commitment to HepQuant Vision and Values

Hands-on work: ability to compile own reports, studies, data

Detail oriented, able to work individually, while also proving their ability to work collaboratively with colleagues, and teammates to create a results-driven, team-oriented environment

Demonstrates a strong professional work ethic, while striving to meet personal and organization performance goals

Excellent written, verbal, and interpersonal communication skills with an acute ability to listen attentively and to communicate effectively throughout all levels of the organization

Professional demeanor and ability to interact with persuasiveness and confidence

Ability to function as a strong member of a highly motivated and integrated team