As a Quality Engineer in New Product Development, you will utilize quality engineering principles and methodologies to ensure compliance with regulatory standards, enhancing product development, manufacturing, and distribution processes for internal and external medical devices.

Key Responsibilities

• Deliver engineering expertise in Quality Assurance, Design Controls, Risk Management, and Statistical Techniques.
• Drive design assurance and development activities, such as engineering studies, feasibility testing, and drawing reviews, for new product development initiatives.
• Develop and maintain risk management documentation in line with ISO 14971 and applicable regulations, including plans, hazard analyses, FMEAs, and software hazard analyses.
• Create quality assurance specifications, test methods, inspection procedures, sampling plans, and related protocols.
• Lead development and validation of test methods.
• Support product launch processes, master validation plans, product V&V, process validations, and the transition of design to manufacturing.
• Provide daily support to production teams, actively engaging in assembly operations and continuously improving systems for compliance and manufacturing excellence.
• Oversee changes to existing products, SOPs, work instructions, test methods, processes, design, labeling, and field issue resolutions, ensuring regulatory requirements are met for submissions and notifications.
• Prepare documentation for regulatory submissions and global product registrations.
• Assist in supplier evaluation, selection, and qualification processes.
• Perform other duties as assigned.

Qualifications

• Bachelor’s degree in Engineering or a related scientific field with 4+ years of experience in Quality Engineering, Quality Manufacturing, or R&D; OR a Master’s degree in a similar field with 2+ years of relevant experience.
• Hands-on experience in Design Assurance, encompassing Design Controls, Design Freeze, Design Verification & Validation, and Design Test Method Development.
• Experience in a highly regulated industry.
• Familiarity with Software Development Life Cycle Processes per IEC 62304 is highly preferred.
• Knowledge of Usability Engineering Processes in line with IEC 62366 is advantageous.

Work Environment & Physical Requirements

• Work is performed in an office setting with no adverse conditions expected.
• Requires prolonged stationary periods and repetitive motions such as typing.
• Involves exchanging information verbally and may include lifting, pushing, or pulling up to 20 pounds.