R&D Quality Engineer

  • location: Scottsdale, AZ
  • type: Contract
  • salary: $40 per hour
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job description

R&D Quality Engineer

job summary:
The Quality Engineer is accountable for supporting new product development and provides quality oversight to the organization while working within a multi-functional team environment for medical devices. The Quality Engineer will handle projects and tasks, from product inception through design transfer and play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and other regulatory requirements.

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: Contract
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards
  • Prepare, review, and/or approve product development documentation (validations, test methods, protocols, reports etc.) in relation to medical devices
  • Supports technical and design review activities as a Quality representative SME
  • Review and approval of qualification documentation and reports
  • Assist and provide guidance on any nonconformance that may occur
  • Work cross-functionally with individuals and project or extended teams to ensure success of projects
  • Drive solutions to ensure customer related problems/issues are communicated
  • Attend program meetings as required as part of extended program teams
  • Liaison with company and customers on Quality matters
  • Provide Quality oversight of qualification/validation/design controls activities
 
qualifications:
  • Bachelor Degree in Engineering or Science required
  • Minimum 2 years of experience in Medical Device Quality & Product Development Lifecycle
  • Experience with customer interface and meeting customer expectations
  • Experience with Medical Device Design & Development, Verification / Validation Activities, Risk Management, Product Transfer, DHF Activities
  • Must have an in-depth knowledge of validations in a Medical Device environment
  • Strong working knowledge of quality systems such as ISO 13485, 21 CFR 820.30
Preferred:

  • 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 they are related to the position
  • Support and contribute in Lean Sigma programs and activities towards delivery of the set target
  • Able to comply with the company's safety & quality policies at all times
 
skills: Quality Assurance, Medical Device Product Development
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.

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