Compliance Engineer Resume
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1163 Ruckman Road
Oklahoma City, OK 73162
(111)-618-2323
e.goley@emailaddress.com
Job Objective: Seeking a position as a Compliance Engineer in a highly established firm that will further boost my career.
Highlights of Qualifications:
Hands on experience of working in a medical device industry as a Quality Compliance Engineer
Sound knowledge of the FDA Quality System Regulations and ISO 13485:2003 requirements
Outstanding knowledge of various engineering design processes
Ability to understand the requirements and coordinate with external vendors
Remarkable ability to handle complaints and provide reports for the same
Skilled to collect the data¸ analyze it and prepared the necessary reports
Exceptional communication skills
Professional Experience:
Compliance Engineer, August 2005 - Present
TRS Technologies, Oklahoma City, OK
Received all complaints for product quality, investigated the complaint by collecting data and prepared reports and recommended corrective actions.
Coordinated with the sub investigators and ensured that the work was completed according to the plan.
Prepared the MDR reports, UFR response letter and compliant report and updated the correction and removal files.
Complied all the investigations carried on various departments such as engineering, manufacturing and service, reviewed them and obtained the results.
Managed all investigations on the return goods that were associated with the complaints.
Documented the inadequacy of the complaint company and provided a feedback.
Prepared documents of the investigation for the various business reviews and maintained a copy to be sent to the related authorities.
Assisted in the FDA inspections carried in the facility and conducted ISO and internal audits.
Coordinated with the departments for product holds, quality control alerts and monitored any corrective action suggested.
Compliance Engineer, May 2000 – July 2005
Coherent, Inc., Oklahoma City, OK
Maintained the complaint systems and prepared reports for the same.
Coordinated the training activities and managed the CAPA system.
Performed yearly audits in accordance to the prepared schedule.
Documented all the training records and the associated reports.
Handled all the Supplier Management and Management review activities.
Scheduled third party auditing such as ISO and FDA.
Education:
B.S in Engineering, Cedar Crest College, Allentown, PA