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Quality Engineer, Post Market (Medical Devices) in Oceanside, CA at Nelson

Date Posted: 4/27/2018

Job Snapshot

Job Description

Job Number: 2119150

Sr. Quality Engineer, Post Market
Oceanside, CA
Up to $110k

This Sr. Quality Engineer, Post Market performs investigations for complex or critical complaints. This position is also responsible for Quality Engineering support related to post-market activities including complaint investigations, Health Hazard Evaluations, Risk Management, and Post Market Surveillance.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
* Perform failure analysis and root cause investigation on returned products including review of Risk Management files and Device History Records.
* Document complaint analysis reports in complaint management system.
* Ensure complaint investigations are completed within the required timeframe.
* Evaluate historical complaint data to identify trends.
* Prepare summary and trend reports for evaluation in Management and other reviews
* Participate in Quality Management Reviews as requested.
* Coordinate and host regularly scheduled reviews of post market data.
* Update Risk Management documentation with post market data.
* Prepare Health Hazard Evaluations to analyze potential field product issues.
* Coordinate recall activities if required.
* Provide trend information to Post Market Surveillance process,
* Define process improvements and implement solutions to improve the efficiency of post market activities.
* Establish and implement post market related procedures and processes.
* Support internal and 3rd party audits with post-market related requests.
* Collaborate with other supporting departments in the resolution of quality problems using established problem-solving methodologies determining root cause and driving corrective and preventive actions where required.
* Other Quality Engineering duties as assigned.

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
* Bachelors Degree in engineering or a related scientific discipline.
* Minimum 7 years experience in the Medical Device Industry working in a Quality functions.
* Demonstrated organizational and communication skills. Strong attention to detail is required.
* ASQ Certification desired
* Demonstrated knowledge of FDA regulations, ISO 13485, CMDR, Medical Device Directive Regulation (93/42EEC), and other National and International regulations and standards.

Demonstrated computer skills. Database and quality data reporting experience required.

Sr. Quality Engineer, Post Market
Oceanside, CA
Up to $110k


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