Guided Therapeutics Inc.
Therapeutics seeks bright, talented and highly motivated
individuals who enjoy working in a fast paced, growing
We offer a
competitive benefits package including medical, dental,
disability and life insurance, supplemental insurance, 401K
savings plan and vision care reimbursement. We also have a
generous vacation, sick time and paid holiday allowance
including an increase in vacation time after five years of
your resume to
firstname.lastname@example.org with your desired position title as
the subject. You may also fax your resume to the attention of
Human Resources at 770-242-8639.
Therapeutics is an Equal Opportunity Employer.
We reaffirm our policy of offering an equal opportunity to all
individuals regardless of race, sex, color, religion, national
origin, age, veteran status or disability. It will continue to
be our policy to seek out and hire, at all levels, qualified
people, without regard to race, religion, age, color,
nationality, sex or disability. Underscoring this policy is our
strong concern for the dignity and well being of our employees.
Title: QA/QC Manager
Code: QOP Position #9
Reports To: Head of Operations
As part of
the Guided Therapeutics, Inc. Operations Department, a QC/QA
Manager is responsible for quality control for the production
floor and the organizationís quality policies and programs.
Assures policies and programs are in compliance with ISO and FDA
quality system regulations
Essential Job Functions
coordinates inspection, sampling, testing, and/or packaging of
supplies/components and finished products.
personnel engaged in quality control/assurance.
manages and tracks the QA teamís efforts, ensuring all products
meet Quality standards and the production process is in
compliance with cGMP, FDA QSR, MDD , ISO13485 requirements.
reports quality findings to senior and executive management,
project/program managers, development team. Follow-up on
leads, improves, and maintains quality methodologies, processes,
assuring company compliance to FDA QSR regulations.
and implements quality specifications, standards and programs
for supplies/components, finished products and/or the packaging
monitors key metrics to assess the quality of products,
supplies, inspection and testing systems.
quality feedback data from customers and consumers to drive
continual improvement activities needed to achieve department
on product defects, product response plans and product
dispositions; recommends and implements improvements.
research and development, engineering, etc., in formulating new
products or in establishing standards for these products prior
to initial production.
statistical data and writes narrative reports summarizing
approves recommendations to change systems, policies, and
procedures; ensures timely and accurate implementation.
in department and inter-department planning and management teams
and works cross-functionally to improve processes within the
obtains staff capabilities needed to accomplish objectives.
handles projects that have short to long-term focus.
planning efforts with day-to-day demands.
employee conformance to established best practices and proper
training of staff.
for ensuring that department understands and complies with
quality standards and requirements as documented.
Science Degree in Life Sciences or related field. MS
engineering/science a plus.
experience with electro-mechanical medical devices.
Experience in Medical Device Production FDA 21 CFR 820, ISO9001,
with cGMP audits from the FDA and other international bodies.
work with cross functional departments and implement successful
NOTE: This job
description is not intended to be all-inclusive. Employee
may perform other related duties as negotiated to meet the
ongoing needs of the organization.