Job Description

NuPulseCV ( is a growing medical device company based in Raleigh, North Carolina.

This position is for a contractor for the next 3-6 months, located in RALEIGH.

Since this is an in-person temporary role, we are looking for someone who does not need work visa sponsorship or relocation.

NuPulseCV is seeking a Quality Engineer to assist in the development and roll out of comprehensive product quality strategies for the full lifecycle of a cardiovascular medical device. Areas of expertise include Design Control, Document Control, and Quality Assurance activities within product development and operations with focus on compliance to FDA and global quality system regulations and standards. The position is a short-term contract with potential for extension or hire.

Essential Job Functions

• Assist in supervision of a comprehensive quality system for a clinical stage Class III cardiovascular support device.
• Manage effective document control and employee training processes and serve as administrator for electronic systems.
• Assist in development and execution of verification testing activities including quality aspects of protocol development and data analysis. Coordinate test documentation and approve test samples.
• Provide quality oversight for all aspects of development, including design control, risk management, usability and design transfer activities.
• Serve as design control expert or independent QA reviewer for design reviews, documentation review, risk assessment and participate in phase reviews, as required.
• Establish and update the design history file (DHF), as required. Review Manufacturing DHFs for completeness.
• Maintain the approved supplier list.
• Create, review, and approve quality system documents, as required.
• Oversee product acceptance activities such as product inspection, nonconforming material, and final release.
• Demonstrate, promote, and create cGMP and GDocP policies and practices to manufacture medical devices. 
• Analyze process and product non-conformances and implement corrective and preventive action plans, as required.

Basic Qualifications

• Knowledge of quality systems and relationship to business.
• Knowledge of medical device regulation, industry or international standards, including design control, risk management, CAPA, and document control.
• Interpretation of regulations and standards (21CFR820, GMP, ISO 13485, ISO 14971, ISO 62304) into procedures.
• Experience reviewing activities related to design verification and design transfer of medical devices.
• Experience with Class II or Class III medical devices.
• Experience configuring electronic quality systems is preferred.
• Experience interfacing with regulatory bodies is preferred.
• Ability to work independently and within a team environment.
• Ability to write reports, business correspondence, and procedural documents.
• Ability to effectively present information and respond to questions from managers, clients, and customers.
• Excellent communication skills (verbal, written, and presentation). Understand how to present information dependent upon the level of the audience.
• Ability to translate quality requirements into product specifications.
• Strong interpersonal skills required in the areas of verbal and written communications, customer focus, professionalism, and leadership.

Education and/or Experience

• B.S. in Engineering, Engineering Technology, or Science a minimum.
• Minimum 3-5 years of experience within an FDA-regulated industry, with preference given to the medical device industry.

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