Quality Engineer II (Medical Devices)

Location: Salem, New Hampshire, USA; onsite

Company

hirify.global designs, develops, and manufactures complex medical devices and component technologies for life-saving applications.

What you will do

• Ensure manufacturing operations comply with GMP, FDA requirements, ISO 13485, 21 CFR Part 820, and applicable customer and regulatory standards.
• Lead root-cause analysis, CAPA investigations, corrective and preventive actions, and effectiveness reviews.
• Conduct gage R&R, SPC, engineering, process validation, and transfer validation studies, including protocol documentation and reporting.
• Drive process improvement initiatives to reduce COPQ, scrap, manufacturing waste, and customer quality escapes.
• Represent Quality on Material Review Board, supplier quality, SCAR, customer complaint, and internal audit activities.
• Create control plans, prepare quality deliverables, support training, and collaborate with Manufacturing and Quality teams on specifications and KPIs.

Requirements

• Experience in quality engineering within a regulated medical device manufacturing environment.
• Ability to apply GMP, GDP, ISO 13485, 21 CFR Part 820, CAPA, SPC, and process validation practices.
• Experience with root-cause analysis, corrective actions, supplier quality processes, SCARs, and customer complaints.
• Ability to design, execute, analyze, and document gage R&R and engineering studies.
• Ability to prepare quality documentation, control plans, validation protocols, and timely deliverables.
• Ability to work onsite in Salem, New Hampshire, USA.

Culture & Benefits

• Collaborative work environment where ideas and contributions are valued.
• Inclusive and diverse workplace culture.
• Investment in employee skill development and career advancement.
• Supportive environment within a growing and dynamic medical technology organization.