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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



SUMMARY DESCRIPTION
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.

ESSENTIAL DUTIES AND RESPONSIBILITIES
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.

DESIRED MINIMUM QUALIFICATIONS
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.

TOOLS AND EQUIPMENT USED
Demonstrated computer skills. Database and quality data reporting experience required.

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

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