Job Summary

A Senior Advanced Quality Engineer for a medical devices and equipment manufacturing company is needed in the Tempe, AZ (hybrid) area. This role leads cross-functional quality assurance efforts in new medical device development, driving risk management, design control, testing methodologies, mentorship, and regulatory compliance to ensure safe and effective products.

location: Tempe, Arizona

job type: Contract

salary: $42.85 - 50.00 per hour

work hours: 8am to 5pm

education: Bachelors

Responsibilities

• Represents Quality Assurance on New Product Development cross-functional teams, collaborating with R&D, Regulatory Affairs, Advanced Operations, and Marketing to meet product development metrics.
• Leads Risk Management activities by creating and maintaining Risk Management Files, identifying hazards, and ensuring compliance with corporate and divisional design control procedures.
• Plans, designs, and implements inspection, testing, and evaluation methods-using advanced statistical techniques for sample-size determinations-to ensure product and production reliability.
• Leads Design Reviews to verify design and process robustness, compliance with regulations (e.g., QSR, ISO 13485), and thorough risk analysis for new medical devices.
• Plans, performs, and reviews engineering risk analyses, test methods, and process improvements to enhance product quality and manufacturing efficiency.
• Provides leadership in product development by guiding engineering principles, interpreting test data, and developing detailed process and product protocols.
• Mentors junior staff, leads departmental initiatives, and influences multiple teams to drive quality and regulatory compliance throughout the development process.
• May interact with customers to address product quality concerns, serve as an independent quality expert, and train on QA/GMP topics.
  
  

Skills: Experience in data collection, data analysis, and scientific method.

Desired Skills

• Experience with Quality Concepts such as Risk Management, CAPA, Audits, Statistics.
• Previous medical device industry experience preferred.
• Understanding of US and International Medical Device Regulations, including ISO 13485, GDP, GMP.
• Six Sigma Green Belt or ASQ CQE.
  
  

Education And Experience

• Bachelor's degree in Mechanical, Electrical, Chemical, Material Science, and/or Biomedical Engineering.
• Minimum of 2+ years of experience in an engineering role.
  
  

Qualifications

• Experience level: Experienced
• Education: Bachelors
  
  

Skills

• Quality
• AutoCAD
• Compliance
• Testing
  
  

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.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.