Quality Engineer; Risk, Project Management & Medical Device

Quality Engineer (Must Have Risk, Project Management & Medical Device) – Urgent Need

Location:

Tempe, AZ

Duration: 6 Months Contract

Total Hours/week: 40

Shift: 1st shift

Quality Engineering role focused on product and service quality evaluation and control. Works cross-functionally in the development and/or maintenance of products or services. Involves resolution of equipment and process-related production issues, including equipment, process, materials and method validation, as well as statistical analysis and metrics to analyze systems and processes being measured.

• Evaluate and control product and service quality; implement quality engineering policies and best practices.
• Collaborate cross-functionally in development and/or maintenance of products or services.
• Identify and resolve equipment and process-related production issues; perform equipment, process, materials and method validation; conduct statistical analysis and monitor relevant metrics.
• Apply basic knowledge of FDA/ISO requirements and quality engineering principles; write test protocols, perform tests, collect data, and prepare reports to validate against plan.
• Assist with regulatory knowledge (cGMP, FDA, ISO) under direct supervision.
• Use basic statistical methods for simple project quality determinations and risk management.
• Develop competence in the assigned area by performing routine work and seeking guidance as needed.

• BS or MS degree.
• Top skills/experience: medical device experience, risk management experience, strong organizational/project management skills.
• Experience with medical devices and preference for candidates with new product development experience.

• Seniority level:
  Entry level
• Employment type:
  
  Contract
• Industries:
  Staffing and Recruiting