RIT Solutions, Inc.
Quality assurance Consultant
6-12 months +
2 days onsite in Bedford, NH
5 openings!!!!
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.
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.