Job Description Job Title: QUALITY ENGINEER Company: CYTEK
BIOSCIENCES, INC. Department: OPERATIONS Supervisor: QUALITY
MAJOR DUTIES AND RESPONSIBILITIES:
The Quality Engineer will support Manufacturing, Supply Chain,
and Customer Facing functions on applicable product quality, design
control, and risk management processes.
Conduct investigation and analysis of failed system modules,
create analysis report and provide recommendations for continuous
Support test method development and evaluate test protocols and
reports to ensure that the testing is sufficient to meet regulatory
requirements and quality objectives.
Generate or apply statistical methods with appropriate risk-based
Provide input to design and manufacturing documentation including
material specifications, drawings, inspection procedures, and
manufacturing procedures, to ensure that the resulting products can
be adequately manufactured and verified.
Promote continuous improvement in design control activities and use
of quality tools.
Define critical to quality characteristics and inspection plans for
components, subassemblies, and finished devices.
Identify and propose remediation for existing and potential quality
Ensure that product changes to existing products are conducted in
compliance with Regulatory and Quality standards.
Maintain expertise in both current and emerging requirements and
quality trends as they relate to life science products and medical
Provide Risk Management support to all quality subsystems.
EDUCATION REQUIREMENTS: Minimum of a BS in Engineering or
Scientific discipline; MS preferred
EXPERIENCE QUALIFICATIONS: Experience in Biotech instrument
development and commercialization activities. Experience with
product risk analysis and management throughout product lifecycle.
Experience with injection molding and assembly preferred. Familiar
with reliability analysis and test methods and test method
validation. Familiar with process validation principles, including
sub-tasks of equipment IQ, OQ, PQ. Working knowledge of 21 CFR Part
820 Quality System Regulation, ISO 13485 Quality Standard, and ISO
14971 Risk Management Standard. tools for managing quality
performance CQE preferred Education 4+ years experience working in
the Medical Device and/or Life Science Research product industries.
Experience interacting with regulatory agencies and notified bodies
and front room audit experience is a plus. Knowledge and experience
with corrective action and preventive action system, release test
statistical sampling methods, quality risk management, FMEA, and
OTHER QUALIFICATIONS: Experience using the Windows OS, MSOffice
Applications, Engineering Change Order Systems, Device History
Records, and the creation of Procedures and Reports.
KEY SKILLS AND COMPETENCIES: Strong verbal (including
presentation) and written communication skills, especially
technical report writing. Demonstrated knowledge of QMS, GMP,
ISO9001, and UL standards. Knowledgeable in manufacturing
techniques and processes. Problem solving, analytical, creativity,
and critical thinking skills. Ability to effectively influence
others without direct authority and partner with internal and
external customers. Company Description Cytek Biosciences Inc. is
the outcome of a merger between Cytek Development Inc, a leading
pioneer in flow cytometry, and Cytoville Inc, a venture capital
backed business in advanced medical instrument technology
development. Cytek was founded by Dr. Eric Chase 25 years ago, and
is a leading manufacturer and supplier of flow cytometry products
and services. We are engineers, scientists and customer service
representatives who design, build and support flow cytometers.
Cytek Biosciences is backed by Cowin Healthcare Fund, Easy
Prosperity and Fidelity Biosciences.
Our mission is to create innovative products and services which
lead to scientific discovery. Our novel, cost-effective products
assist labs around the world to operate safely and efficiently.
Cytek's products add functionality to existing flow cytometry
equipment, extending its usable life. Our onsite support services,
provide cost effective maintenance solutions for a broad range of
As a Company, we seek to maintain high ethical standards and a
culture that values honesty, integrity and transparency in all that
we do. Company decisions are driven by what is right for scientific
discovery and customer support. We are committed to our employees,
to the environment in which we live and to the communities we serve