Careers at Guided Therapeutics

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Careers At Guided Therapeutics Inc.

Guided Therapeutics seeks bright, talented and highly motivated individuals who enjoy working in a fast paced, growing environment.

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 service.

Please email your resume to careers@guidedinc.com with your desired position title as the subject. You may also fax your resume to the attention of Human Resources at 770-242-8639.

Guided 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.


Job Title:  QA/QC Manager

Job Code:  QOP Position #9

Department: Production

Reports To: Head of Operations

Position Overview

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

Manages and coordinates inspection, sampling, testing, and/or packaging of supplies/components and finished products.

Oversees personnel engaged in quality control/assurance.

Coordinates, 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.

Documents and reports quality findings to senior and executive management, project/program managers, development team.  Follow-up on ongoing issues. 

Manages, leads, improves, and maintains quality methodologies, processes, and procedures.

Responsible in assuring company compliance to FDA QSR regulations.

Establishes and implements quality specifications, standards and programs for supplies/components, finished products and/or the packaging thereof.

Develops and monitors key metrics to assess the quality of products, supplies, inspection and testing systems.

Utilizes quality feedback data from customers and consumers to drive continual improvement activities needed to achieve department strategic goals.

Reviews data on product defects, product response plans and product dispositions; recommends and implements improvements.

Assists research and development, engineering, etc., in formulating new products or in establishing standards for these products prior to initial production.

Compiles statistical data and writes narrative reports summarizing quality findings.

Develops or approves recommendations to change systems, policies, and procedures; ensures timely and accurate implementation.

Participates in department and inter-department planning and management teams and works cross-functionally to improve processes within the organization.

Identifies and obtains staff capabilities needed to accomplish objectives.

Oversees and handles projects that have short to long-term focus.

Balances planning efforts with day-to-day demands.

Ensures employee conformance to established best practices and proper training of staff.

Responsible for ensuring that department understands and complies with quality standards and requirements as documented.

 Requirements

Bachelor of Science Degree in Life Sciences or related field.  MS engineering/science a plus.

Hands on experience with electro-mechanical medical devices.

10+ years Experience in Medical Device Production FDA 21 CFR 820, ISO9001, ISO 13485

Familiarity with cGMP audits from the FDA and other international bodies.

Ability to work with cross functional departments and implement successful manufacturing strategies

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.


   
   
 

©2014 Guided Therapeutics, Inc.

5835 Peachtree Corners East

Suite D

Norcross, GA 30092

770-242-8723

770-242-8639 - Fax

www.guidedinc.com

info@guidedinc.com

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