Senior Quality Engineer

TL;DR

Senior Quality Engineer: Executing sustaining and project quality engineering for the Peripheral Vascular Health (PVH) platform with an accent on quality voice across capacity expansion, equipment end-of-life replacement, yield improvement, technology change implementation, and quality improvement initiatives. Focus on deep technical analysis using DOE, SPC, hypothesis testing, capability studies, and Gemba walks to determine root cause, drive corrective actions, and ensure regulatory compliance through CAPA, documentation, and risk assessments.

Location: Plymouth, Minnesota, United States of America (in-person/on-site; minimum 5 days a week onsite)

Salary: $98,400.00 - $147,600.00 (USD)

Company

hirify.global is a global healthcare technology company focused on solving challenging health problems.

What you will do

• Act as the quality representative on site projects and support the PMO roadmap.
• Generate actionable ideas to improve quality, safety, and yield while reducing cost and cycle time.
• Perform in-depth analysis to determine root cause and identify corrective actions using tools such as DOE, SPC, hypothesis testing, capability studies, and Gemba walks.
• Ensure processes and procedures comply with applicable regulations.
• Produce detailed engineering analysis and documentation for product disposition, process changes, and CAPA.
• Create and/or support test plans and reports, including qualifications, risk assessments, and work instructions.

Requirements

• Bachelor’s degree with at least 4 years of relevant experience, or Master’s degree with at least 2 years of relevant experience, or PhD with 0 years of relevant experience.
• Ability to work in-person/on-site at the Plymouth Nathan Lane facility (minimum 5 days a week onsite).
• U.S. work authorization requirements: unrestricted U.S. work authorization at time of hire and for duration of employment (U.S. work authorization sponsorship is offered exclusively for Principal-level roles and above).
• Experience applying technical skills/tools for quality analysis and corrective actions (e.g., DOE/SPC/capability studies) and producing engineering documentation.

Nice to have

• Experience reviewing technical documentation.
• Process validation experience (installation qualifications, process characterization, operational and performance qualifications).
• Experience developing, executing, and analyzing Test Method Validations.
• Experience with Master Validation Records and Risk Management documentation (DFMEA, PFMEA).
• Strong written and verbal communication and critical thinking/analytical skills; general understanding of project management.

Culture & Benefits

• In-person/on-site role with very limited travel; minimum 5 days a week onsite.
• Eligible for a short-term incentive (hirify.global Incentive Plan, MIP).
• Health, dental, and vision insurance plus Health Savings Account and Healthcare Flexible Spending Account (for regular employees working 20+ hours/week).
• 401(k) plan with employer contribution and match, paid time off, paid holidays, and tuition assistance/reimbursement.
• Life insurance, long-term disability leave, and employee assistance program.

Hiring process

• Application review within the stated application window (closing 26 Jun 2026).
• Interviews and evaluation of technical/quality engineering experience and documentation capabilities.