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4 дня 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 processes, documentation, metrics, and audit readiness in alignment with ISO 13485 and FDA requirements, while managing orders, complaints, returns, and customer changes. with an accent on SAP transaction accuracy, cross-functional issue resolution, and customer-facing quality operations. Focus on optimizing QMS processes, coordinating corrective actions, and ensuring reliable shipment and complaint documentation.

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

Salary: $93,600–$140,400 per year, plus eligibility for a short-term incentive plan.

Company

hirify.global develops healthcare technologies intended to alleviate pain, restore health, and extend life, serving patients across more than 150 countries.

What you will do

  • Own and optimize customer-related Quality Management System processes in alignment with ISO 13485, FDA requirements, and internal standards.
  • Define, track, analyze, and improve metrics for orders, complaints, returns, turnaround times, and service quality.
  • Maintain QMS procedures, work instructions, forms, templates, and audit-ready documentation.
  • Serve as the primary customer interface for orders, changes, complaints, feedback, RMAs, returns, and issue resolution.
  • Coordinate purchase orders, forecasts, sales orders, shipment transactions, invoices, and shipping documentation using SAP and MES.
  • Partner with Quality, Engineering, Planning, Operations, Finance, and Commercial teams to manage changes, investigations, corrective actions, and customer commitments.

Requirements

  • Baccalaureate degree, or an equivalent qualifying foreign degree under 8 C.F.R. § 214.2(h)(4)(iii)(A).
  • 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; sponsorship is not available for this role.
  • Ability to work onsite in Tempe, Arizona five days per week.
  • Strong analytical, communication, documentation, and cross-functional collaboration skills.

Nice to have

  • Experience with SAP sales orders, shipment transactions, or customer-related configuration.
  • Familiarity with ISO 13485 and FDA quality system requirements.
  • Experience handling complaints, RMAs, customer feedback systems, or customer-requested changes.
  • Experience working with Planning, Engineering, Operations, and Finance on customer commitments and quality outcomes.

Culture & Benefits

  • Professional growth and cross-functional collaboration in an in-person work environment.
  • Health, dental, and vision insurance, plus health and dependent-care spending accounts.
  • Life insurance, long-term and short-term disability coverage, paid time off, and paid holidays.
  • Tuition assistance, employee assistance resources, incentive plans, and employee stock purchase plan.
  • 401(k) plan with employer contribution and match, subject to applicable eligibility rules.

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