1 день назад
Quality Assurance Engineer (Medical Devices)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Assurance Engineer (Medical Devices): Leading quality assurance activities across new product development and sustaining engineering programs with an accent on design controls, risk management, audit readiness, and regulatory compliance. Focus on developing DFMEA/UFMEA documentation, reviewing verification and validation records, investigating systemic quality issues, and managing CAPA solutions.
Location: Brisbane, Australia; hybrid working with 2–3 office-based days per week
Company
is a medical technology company developing clinically differentiated orthopedic and healthcare solutions focused on patient outcomes and workflow transformation.
What you will do
- Represent Quality Assurance on new product development and sustaining engineering projects.
- Participate in design and manufacturing reviews and approve design control documentation, including specifications and verification and validation records.
- Develop and maintain DFMEA and UFMEA documentation and lead ISO 14971-aligned risk management discussions.
- Prepare for, support, and act as a design quality subject matter expert during internal and external ISO, FDA, and GMP audits.
- Maintain quality system procedures, work instructions, and controlled documentation, and conduct internal audits.
- Investigate product failures, complaints, and nonconforming materials while leading root cause analysis and CAPA activities.
Requirements
- Bachelor’s degree in Engineering, Mechanical Engineering, or a related field.
- At least 2 years of experience in Quality Assurance or a related function within a regulated industry.
- Experience in medical devices, aerospace, automotive, or another highly regulated industry.
- Working knowledge of ISO 13485 and quality system regulations, with experience supporting software as a medical device.
- Strong technical writing, analytical, problem-solving, and controlled documentation skills.
- Proficiency in Microsoft Office, especially Excel and Word.
Nice to have
- CQE, Lean, or Six Sigma certification.
- Experience with ISO 14971 risk management, FDA and international regulatory audits, design controls, and product or software lifecycle processes.
- Familiarity with SolidWorks, eQMS, Power BI, Oracle R12, or Agile PLM.
Culture & Benefits
- Hybrid working arrangement with 2–3 office-based days per week.
- Cross-functional collaboration across engineering, manufacturing, regulatory, and quality teams.
- Work focused on medical device safety, compliance, continuous improvement, and patient outcomes.
- Primarily computer-based work with occasional standing or extended desk work.
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