Browse thousands of jobs & apply anytime, anywhere.

Quality Engineer w/ CareFusion in Atlanta, GA job in Tucker, GA

Share:

Job summary

Quality Engineer w/ CareFusion in Atlanta, GA
Location: Tucker, GA Category: Engineering
Status: Temporary/Contract Reference: US_EN_2_103871_258425
Posted: July 30,2014 Salary: N/A

Print image email image
Apply Now

Job description

A Quality Engineer job with CareFusion in Atlanta, GA is available courtesy of Adecco Engineering and Technical.


Summary of Job Functions:
The primary objective of this position is to perform equipment and process validations. This is a temporary, twelve month position.

Principle Accountabilities:
Develop, execute and summarize validation and qualification protocols and associated reports.
Lead process validation activities and update the master validation plan.
Update validation templates to make them more user friendly and consistent.
Review, update and create documents as necessary to support validation activities.
Develop applicable quality inspection specifications and methods to support validation activities.

Validations to consist of but are not limited to:
Qualifications (Installation, Operational, Performance)
Equipment - Ovens, High Potential Testers, Comparators, Autoclaves, Manual Equipment
Software
Process Validations
Assembly, Passivation, Laser Etching

Demonstrates a understanding of ISO 13485:2003, 21 CFR Part 820 Quality System Regulations, Medical Device Directive, Canadian Medical Device Regulations, JPAL and other regulations to ensure compliance of the quality system.

Effectively manages risk for the facility, using techniques defined within ISO 14971, and imbedding strong risk management principals into daily situational management.

Applies analytical and problem solving techniques in the normal course of daily activities.

Demonstrates working knowledge of FDA/ISO requirements

Applies statistical sample size calculations to work for quality determination on projects of intermediate scope/complexity

Applies working understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with minimal supervision

Requirements:
BS in Engineering or Science discipline preferred
Competencies to include: analytical, team interaction and communication skills.
Must have computer skills and a working knowledge of Microsoft Windows applications i.e. Word,
PowerPoint and Excel
Minimum 3 years experience in Quality Engineering Regulatory functions is preferred with understanding of FDA regulations and applicable standards in the fields of medical device or
pharmaceuticals.
Demonstrated ability to concurrently handle multiple project assignments and to lead or participate
on cross-functional project teams.
Demonstrated application knowledge of 21 CFR 820, ISO 13485, CMDR and EEC 93/42
Minimum 3 years experience in Quality Engineering Regulatory functions is preferred with understanding of FDA regulations and applicable standards in the fields of medical device or
pharmaceuticals.
Demonstrated ability to concurrently handle multiple project assignments and to lead or participate
on cross-functional project teams.
Demonstrated application knowledge of 21 CFR 820, ISO 13485, CMDR and EEC 93/42



Print image email image
Apply Now