Quality Engineer II (Medical Devices)

Location: Tempe, Arizona, United States; onsite 5 days per week

Salary: $79,200–$118,800 per year

Company

hirify.global develops healthcare technologies focused on alleviating pain, restoring health, and extending life through medical devices and related solutions.

What you will do

• Develop and maintain quality standards, protocols, inspection methods, testing procedures, and compliant quality systems.
• Partner with engineering and manufacturing teams across wafer, sensor, and hybrid manufacturing operations.
• Support equipment development, IQ, process characterization, OQ/PQ, and test method development and validation.
• Apply acceptance criteria, statistical analysis, and design of experiments to manufacturing test plans and reports.
• Support risk assessments, process FMEA, CAPA investigations, nonconformance investigations, containment, and effectiveness verification.
• Drive change control, quality metrics, technical solutions, and cross-functional project leadership.

Requirements

• Bachelor’s degree in engineering, science, or a technical field with at least 2 years of relevant experience, or a master’s degree with no required experience.
• Experience with quality engineering, process development, validation, manufacturing, or related technical work.
• Must possess unrestricted U.S. work authorization at the time of hire and throughout employment.
• U.S. work authorization sponsorship is not available for this role; sponsorship is limited to Principal-level roles and above.
• Foreign bachelor’s degrees must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).

Nice to have

• Experience with electronics manufacturing, wafer fabs, microelectronics assembly, SMT, or chip-and-wire processes.
• Experience with medical device manufacturing, process quality, regulatory compliance, FDA, MDSAP, TUV, ISO, or FDA-GMP requirements.
• Six Sigma or Lean Sigma certification.
• Applied statistical analysis and design of experiments experience.
• Strong technical writing, presentation, and communication skills.

Culture & Benefits

• Onsite collaboration focused on professional growth and cross-functional teamwork.
• Health, dental, and vision insurance, with HSA and healthcare FSA options for eligible regular employees.
• Paid time off, paid holidays, short-term and long-term disability coverage, and life insurance.
• 401(k) plan with employer contribution and match, employee stock purchase plan, and incentive plans.
• Tuition assistance, dependent daycare spending account, employee assistance, and global well-being programs.