Design Assurance Engineer

About the Company

We are seeking to hire a Quality Design Assurance Engineer to join our QA team. As a Design Assurance Engineer, you will lead all quality elements of Design Controls and product DHF for new product introductions and sustaining/design projects. Reports to: QA Manager

Responsibilities

• Quality responsibility to verify that the design and development process follows the procedures and design and development plans.
• Work closely with R&D and test teams to support regulatory requirements by creating, reviewing, and providing quality and compliance input to the design and development process, deliverables, and requirements.
• Participation in project meetings to review and help update clear and concise user requirements, product specifications, plans, verification and validation studies, risk management files, and other relevant design control deliverables.
• Quality responsibility for transferring new products and sustaining projects to manufacturing and operations quality and supplier quality teams.
• Support the Regulatory Affairs department for submissions and respond to submission questions, implementation of new or revised standards and support internal and external audits.

Qualifications

• At least 2-3 years of experience working in a quality function in the medical device industry – must.
• At least 1 year of experience as a design control engineer (preferred).
• A Bachelor of Science in Engineering, Sciences, or a related field – must.
• Familiar with statistical techniques used in verification and validation processes – must.
• Experience with ISO 14971, 21 CR 820, ISO 13485, EU MDR, IEC 60601-1, IEC 62366, and IEC 62304 standards – must.
• Strong analytical and problem-solving skills, with keen attention to detail.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.
• Proficient use of standard MS Office applications.
• Fluent in English (oral and written).