For The Candidates

Qa Eng III, quality engineer medical device
GA
Type: Full-Time
Category: Quality Assurance
Job ID: 743
Opportunity Description:

(770)    Atlanta Area

 

QUALITY VALIDATION ENGINEER III

OBJECTIVE:

Utilize quality engineering techniques and practices to ensure that raw materials, components, and products received, processed, and released for distribution by our company meet or exceed their intended performance requirement for safety and efficacy.

RESPONSIBILITIES:

Design, prepare, execute, and analyze installation qualifications (IQs), operational qualifications (OQs), performance qualifications (PQs), and process validations (PVs) to approve equipment, processes, and software used in the testing, processing, storing, and distribution of products.

Assist in the implementation of corporate policies and procedures relating to quality, project management, process development, and QSR/ISO compliance by establishing procedures and integrated program plans for achieving reliability in accordance with specifications and procedures.

Provide assistance and technical support to all of our projects, facilities, and subsidiaries.

Provide quality engineering support in resolving supplier-related quality issues.

Collect, statistically analyze, and develop report packages to support all validations/qualifications.

Develop, conduct, and document qualifications/validations to ensure that the products processed are proven to be reliable, safe, and effective prior to release.

Assist in the evaluation of product complaints.

QUALIFICATIONS:

Minimum of a Bachelor's degree in an engineering field, or equivalent work experience.

MINIMUM of 4 years hands-on validation experience, preferably in a pharmaceutical, biomedical, or medical device field (regulated industry), with an in-depth knowledge of current Good Manufacturing Practices, Quality System Regulations, and ISO Standards.

Specific experience preferred in the areas of sterilization equipment/processes for gamma, ETO and steam, HVAC systems, USP Purified & WFI systems, and Validation Master Planning.

ASQ CQE certification preferred, not required. Personal computer skills, i.e., word processing, spreadsheets, data analysis.

 

 
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