The R&D Quality Engineer will provide quality oversight support to the organization while working within a multi-functional team environment. The Quality Engineer will perform quality related responsibilities such as creating product specifications, incoming/in-process documentation, deviations, change controls, analyzing data to support development, while reviewing and approval technical documentation including: validation protocols, protocol reports, Gage R&R reports, and design controls related documentation.
The Quality Engineer will also execute transactions in relevant GMP systems (MasterControl, SAP, Share Point) and other relevant quality functions as applicable including site audit support.
location: Scottsdale, Arizona
job type: Temporary
salary: $30 - 35 per hour
work hours: 9 to 5
- Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards
- Supports technical and design review activities as a Quality representative SME
- Work cross-functionally with individuals and project or extended teams to ensure success of projects
- Attend program meetings as required as part of extended program teams
- Provide Quality oversight of qualification/validation/design controls activities
- Other duties as assigned
- Minimum Bachelor Degree in Engineering or Science
- Minimum 2 years of experience in quality related environment
- Familiar with regulatory guidance such as ISO 13485, 21 CFR 820.30
- Previous experience with MasterControl, SAP, Share Point, Teamcenter
- Strong project management skills
- Excellent written and verbal communication skills, including facilitation and presentation skills
- Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
- Support and contribute in Lean Sigma programs and activities towards delivery of the set target
- Able to comply with the company's safety policy at all times
- Able to comply with the company's quality policy at all times.
skills: Quality Assurance, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.