Quality Engineer @ Tempe, AZ - Permanent - Urgent Hiring

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