| 연락처 | john@tylent.com |
|---|---|
| 지역 | Tempe, Arizona |
| 희망 급여 | 110K to 115K Per Annum |
Hi,
Hope you are doing well!
Exclusively hirng for "Quality Engineer" @ Tempe, AZ (Onsite). Interested, please share resume at john@tylent.com
Position: Staff Quality Engineer - Product Development
Location: Tempe, Arizona (Onsite)
Salary: 110K to 115K Per Annum
Duration: Fulltime / Direct Hire
Ideal Candidate:
8+ years’ experience in New Product Development of combination devices
Skills and Certifications:
Drug Device delivery combination products
Required Education and Experience:
BS in Engineering, Biological Science, or a related engineering field (Masters or Ph.D preferred). Fields of study include Chemical Engineering, Bioengineering, Pharmacy, or Biochemistry
Minimum of eight years of experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry
Extensive proven understanding of design controls in development stage
Understanding of regulatory requirements including ISO 13485, ISO 14971, 21 CFR 210/211/820 , ICH Guidelines
Pharmaceutical or combination product experience
Required Qualifications:
· Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.)
· Ability to lead creation of risk management files
· Ability to develop solutions with business impact
· Advanced statistical and risk assessment techniques
· Working knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies
Thanks!
John
