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4 часа назад

Senior Quality Systems Specialist (MedTech)

93 600 - 140 400$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Senior Quality Systems Specialist (MedTech): Owning and improving customer-related quality management system processes for medical technology operations with an accent on ISO 13485, FDA compliance, customer complaints, RMAs, and SAP transactions. Focus on designing QMS documentation and metrics, maintaining audit readiness, coordinating customer changes and issue resolution, and ensuring accurate order and shipment execution.

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

Salary: $93,600–$140,400 per year, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global is a global healthcare technology company developing medical technologies intended to alleviate pain, restore health, and extend life.

What you will do

  • Own and optimize customer-related Quality Management System processes in alignment with ISO 13485, FDA requirements, and internal standards.
  • Develop quality metrics, reports, procedures, work instructions, forms, and templates, and maintain audit readiness.
  • Act as the primary interface for assigned external customers regarding orders, changes, complaints, returns, and issue resolution.
  • Create and manage customer sales orders, shipment transactions, invoices, and shipping documentation in SAP.
  • Coordinate customer-requested changes through customer portals and translate requirements into documented internal actions.
  • Collaborate with Quality, Engineering, Planning, Operations, Finance, and Commercial teams to investigate issues and improve customer-related processes.

Requirements

  • Baccalaureate degree, or an equivalent foreign degree meeting the stated U.S. regulatory requirements.
  • At least 4 years of relevant experience, or an advanced degree with at least 2 years of relevant experience.
  • Unrestricted U.S. work authorization is required at the time of hire and throughout employment.
  • Ability to work onsite in Tempe 5 days per week and communicate effectively with internal and external stakeholders.

Nice to have

  • Experience with SAP sales order creation, shipment transactions, or customer-related configuration.
  • Familiarity with ISO 13485 and FDA quality system requirements.
  • Experience handling complaints, RMAs, or customer feedback systems.
  • Experience collaborating with Planning, Engineering, Operations, and Finance.
  • Strong analytical, reporting, and process improvement skills.

Culture & Benefits

  • Purpose-driven work focused on healthcare technology and patient outcomes.
  • Health, dental, vision, life, and disability insurance options.
  • Health Savings Account, Healthcare Flexible Spending Account, and dependent daycare spending account.
  • 401(k) plan with employer contribution and match, incentive plans, paid time off, and paid holidays.
  • Tuition assistance or reimbursement, Employee Stock Purchase Plan, Employee Assistance Program, and global well-being resources.

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