Quality Verification and Validation Test Lead

Quality Verification and Validation Test Lead

Sunrise is looking for a versatile individual with deep skills and experience in medical device development to participate in product development, supervise product verification and perform compliance activities.

• A comprehensive benefits package including 100% company paid Dental, Life and Disability insurance
• Three weeks of Vacation time, additional Sick pay plus 10 paid holidays
• Monthly lunches and socials, Bagel Tuesday

• Plan and Direct verification testing of electrical, mechanical, and software components and systems as applicable
• Design test protocols; oversee test execution
• Direct quality engineering in identifying, recommending, implementing, managing, and administering process and software validation
• Support proposal creation and estimates
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• Participate in internal and external audits

• Bachelor’s degree in Engineering, Computer Science, or similar technical discipline. 6+ 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.
• Must be able to work onsite at least 3 days a week.
• 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.

• Seniority level:
  Mid-Senior level
• Employment type:
  
  Full-time
• Job function:
  Analyst, Engineering, and Quality Assurance
• Industries:
  Medical Equipment Manufacturing, Software Development, and Engineering Services

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