- Strong experience with Medical Device product and process quality issues
- Deviation Investigation expertise
- In addition to strong ISO 13485 Experience, previous experience with ISO 14971 risk and hazard analysis
- Complete all aspects of product and process deviation documentation
- Take part in risk mitigation, maintenance and analysis projects
- Perform DOEs to support the continuous improvement goals when necessary
- Ability to work autonomously and independently
- Perform other duties as assigned
- 4+ years of experience in Medical Device Quality functions
- GMP, ISOs (13485, 14971), 21CFR 210, 211 & 820, and Six Sigma experience readily demonstrated
- Strong planning and organizational aptitude
- Excellent problem solving mentality/disposition
- CQE / CQA /Black Belt Certification (any)
- Engineering Degree
- Advanced Degree (MS / ME)
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Quality Engineering Coordinator
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Senior Quality Engineer - Scottsdale, United States - Ursus Inc
Description
JOB TITLE:
Senior Quality Engineer
TOP 3 SKILLS:
LOCATION:
Greater Pheonix, AZ Area
DURATION:
6 month extendable assignment
RATE RANGE:
60-70/hr
SUMMARY:
Seeking a highly-skilled and experienced Medical Device Quality Engineer for assignment within the Quality department at a Medical Device Manufacturing facility.
RESPONSIBILITIES:
QUALIFICATIONS:
NICE TO HAVE:
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