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.