Quality Engineer II
Company: SomaLogic, Inc.
Posted on: May 3, 2021
Position Summary: SomaLogic is a privately-owned biomedical
science company that developed a revolutionary proteomics
technology capable of measuring thousands of different human
proteins in a single small sample. We are now moving towards
commercializing the health-related information derived from that
technology to help people worldwide proactively manage their health
for life. As a part of our commercialization effort, we are seeking
a Quality Engineer with experience in reagent development,
manufacturing, and validation to join our dedicated team of
engineers, scientists, bioinformaticians, statisticians, and
software developers to help us realize that vision. This position
will report to the Senior Director, Regulatory & Quality and act as
the subject matter expert and principal contributor of SomaLogics
quality engineering initiatives with regards to reagent products
and methods. SomaLogics products span a broad range of regulatory
and quality requirements across multiple international markets,
from IVD (US and International), to CLIA and Lab Developed Tests
(LDT), to software as a medical device (SaMD). The individual in
this role will be relied upon to ensure the robustness of reagent
products and their compliance with new and developing quality
standards and regulatory requirements. The level of the role will
be commensurate with experience of the selected candidate. Key Job
Responsibilities: ? Author and review validation protocols and
reports for activities related to reagent development,
manufacturing processes, and process equipment. ? Determine
validation strategy based on acceptable risk-based approach. ?
Review the quality, validation impact, and completeness of change
order requests and change controls for all aspects of reagents and
chemistry. ? Lead cross-functional team to write Process Failure
Mode Effect Analysis (PFMEA) of manufacturing and laboratory
operations. ? Manage projects with multiple validation deliverables
in timely manner. ? Perform process risk assessments for
Non-Conformance Reports (NCRs). Provide quality input to product
disposition. ? Provide technical support (subject matter expert)
during audits (internal and third-party audits). ? Propose, plan
and execute improvement projects for the quality department as well
as for supported operations and development teams. ? Participate in
Material Review, Change Control, and Equipment Review board
meetings. ? Create and maintain key quality metrics for supported
departments and own projects. ? Conduct reviews of product and
manufacturing changes for compliance with applicable regulations
including protocols and reports to support regulatory submissions.
? Comply with U.S. Food and Drug Administration (FDA) and
international regulations, other regulatory requirements, Company
policies, operating procedures, processes, and task assignments
Qualifications: Education Bachelors degree in a Scientific or
Technical field (i.e. Sciences or Engineering); Advanced degree,
CQE, or six sigma certifications preferred Skills and experience ?
Minimum of 3 years in a Quality or Operations function within,
ideally, In Vitro Diagnostics or else a related field (pharma, or
medical device). ? Proficient in validation methods and evaluation
criteria. ? Experience with process validation and equipment
qualification is required. ? Experience with facilities
qualification, cleaning validation and/or analytical method
validation is preferred. ? Knowledge of manufacturing processes
(bulking, filling, and/or synthesis) is preferred. ? Experience
with change control systems. ? Experience with electronic document
management systems. ? Understanding of basic statistics and
acceptance sampling. ? Experience with PFMEAs is preferred. ?
Knowledge of CDRH, and ISO regulations. Experience with CLIA
regulations desirable. ? Experience with FDA-compliant design
control, change control, process control and quality systems for in
vitro diagnostics highly desired. ? Demonstrated computer skills
with word processing, spreadsheets, graphics, and statistical tools
in support of preparing technical documentation and change reviews.
? Strong verbal and written communications with ability to
effectively communicate at multiple levels in the organization. ?
Multitasks, prioritizes and meets deadlines in timely manner.
Strong project management, organizational, and follow-up skills, as
well as attention to detail in preparation of materials and their
review. Work Environment: Work is in typical office environment but
may require occasional work in a typical laboratory environment
with personal protective equipment use required. This position may
require up to 10% travel.
Keywords: SomaLogic, Inc., Boulder , Quality Engineer II, Other , Boulder, Colorado
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