Title: QA Engineer (Local to NH)
Visa: USC, HR-EAD, OPT-EAD
Duration: 6-12 months
Location: 2 days onsite in Bedford, NH | ( Need Local)
Interview: 2 Videos
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Position Overview:
Sunrise is looking for a versatile individual with deep skills and experience in medical device development to participate in product development, product verification and perform compliance activities.
Key Responsibilities:
Execute testing of electrical, mechanical, and software components and systems as applicable.
Follow test protocols; execute testing; complete verification and validation activities
Assist in identifying, recommending, implementing, managing, and administering process and software validation.
Participate in internal and external audits.
We’re Looking For:
3+ years’ experience in Quality assurance including medical device design controls.
Knowledge of ISO 13485, and global quality assurance requirements for medical devices, including IEC 60601-1
Solid understanding of IEC 62304 Medical Software Development Process
Familiarity with Risk Management standards ISO 14971
Excellent analytical and decision-making skills, as well as strong written and verbal communication
Ability to speak effectively before groups of clients or employees.
Experience using a variety of software development methodologies (Waterfall, Phase Gate, Agile, SCRUM, Kanban, etc.) is a plus.
Experience in modern test automation is a plus.
Himani Chaudhary
Direct: (972) 392-5968
Office:-972 934 5200 Ext:-203| [email protected]
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