Quality Assurance Specialist

1 month ago


Tempe, Arizona, United States MILLENNIUMSOFT Full time
Job Title: Quality Assurance Specialist

Millenniumsoft is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services.

Key Responsibilities:
  • Provide quality engineering representation on various project teams
  • Initiate new or revised documentation
  • Develop and validate test methods, equipment qualifications, and process validation requirements
  • Lead cross-functional teams to develop risk assessments and design verification and validation protocols
  • Conduct and coordinate testing outlined in protocols and test methods
  • Perform process improvement, control, and monitoring on manufacturing processes
  • Provide technical direction during design transfer activities
  • Participate in 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
Requirements:
  • Minimum of 3 years' experience with either New Product Development or Sustaining Products
  • Strong experience with developing/designing design input requirements (DIRs) and risk management documentation (Design FMEAs) is a plus
  • Medical Device experience is strongly preferred, but not required
  • Quality Engineering experience desirable, but not mandatory
  • Ability to make and present engineering decisions
  • Able to perform PCB/system level design reviews or PCB testing
  • Demonstrated Project Management skills
  • Understanding and application of DOE
  • Ability to analyze and optimize manufacturing and quality systems
  • Advanced product, design & prototyping skills and perform design review functions
  • Ability to create, review, and coordinate test protocols and reports
  • Ability to generate engineering proposals
  • In-depth knowledge of regulatory requirements
  • Ability to develop and control a budget and understand engineering cost analysis
Additional Skills:
  • Advanced statistics and software application skills
  • Advanced problem-solving skills
  • Ability to create/provide training, manage technical personnel, and lead cross-functional teams
  • Strong interpersonal skills and must read, write, speak, and understand English
  • Must be detailed in handling information/data and have excellent oral and written presentation skills
Education:
  • BS in Electrical Engineering (EE) or Computer Science/Systems (CS) or Software Engineering (SE) strongly preferred, or
  • BS in Engineering (Biomedical, Mechanical, Materials, Chemical), ideally with practical work experience in electrical or software technologies


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