Sr. Quality Engineer - Tempe, AZ

Seeking a Sr. Quality Engineer to work for a global medical technology company in Salt Lake City, UT or Tempe, AZ location.  This position develops implements and improves commercial product quality requirements.

This is a high-level quality engineering position which requires a high-energy individual with excellent teamwork, partnering and negotiation skills. Must demonstrate good judgment in selecting methods and techniques for obtaining solutions. High level and hands-on engineering position that leverages medical device development / quality / manufacturing experience in product and process development. Excellent verbal and written communication skills, detail orientation and analytical/problem solving skills are a must. Must be a highly motivated self-starter with the ability to achieve results with minimal direction.

Responsibilities:

  • Provide Quality Engineering support on Product Engineering Teams.
  • Provide on-going support to manufacturing site(s) for commercially available products
  • Initiate new or revised documentation
  • Lead cross-functional teams to develop risk assessment for proposed changes to commercially available products (i.e. material / spec changes)
  • Lead periodic product franchise reviews.
  • Develop physical and functional test methods to ensure specifications are met.
  • Write, review and approve design verification and validation protocols and reports.
  • Develop processes validation requirements (IQ, OQ, PQ) and equipment qualifications.
  • Conduct and /or coordinate testing outlined in protocols and test methods.
  • Perform process improvement, control and monitoring on manufacturing processes.
  • Participate during design transfer activities.
  • Conduct complaint investigations.
  • Participate and provides input to training on department/division procedures, and policies.
  • Develop and implement procedures to comply with corporate and industry standards.
  • Understand and follow company procedures on regulatory requirements.
  • Provide support to the regulatory department in writing technical submissions.
  • Provide positive example and actively promotes compliance to all standards.
  • Maintain a professional working relationship with internal and external customer and support staff.
  • Prepare and present project updates and technical discussions.

 

Requirements:

  • Bachelor’s or Master’s degree in Engineering discipline.
  • A minimum of 6 years experience in the medical field or closely related industry or a Masters Degree and three years experience.
  • Ability to make and present engineering decisions
  • Strong interpersonal skills
  • Demonstrated Project Management skills
  • Advanced statistics
  • Understanding and application of DOE
  • Ability to lead cross functional teams
  • Engineering cost analysis
  • Ability to analyze and optimize manufacturing and quality systems
  • Advanced product, design & prototyping skills
  • Ability to create and provide training
  • Software application skills
  • Advanced problem-solving skills
  • Ability to create, review and coordinate test protocols and reports
  • Ability to generate engineering proposals
  • Oral and written presentation skills
  • In-depth knowledge of regulatory requirements
  • Ability to develop and control a budget
  • Ability to manage technical personnel
  • Ability to perform design review functions
  • Must read, write and understand English. Must be detailed in handling information/data.
  • U.S. citizen/green card holder required.