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Senior Quality Engineer - Scottsdale, United States - Ursus Inc
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Description
JOB TITLE: Senior Quality Engineer
**TOP 3 SKILLS:**
1. Strong experience with Medical Device product and process quality issues
2. Deviation Investigation expertise
3. In addition to strong ISO 13485 Experience, previous experience with ISO 14971 risk and hazard analysis
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.
Project will focus on non-conformities, deviations, CAPAs and validation work.
RESPONSIBILITIES:
- 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
QUALIFICATIONS:
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
NICE TO HAVE:
- CQE / CQA /Black Belt Certification (any)
- Engineering Degree
- Advanced Degree (MS / ME)
IND123