Design Assurance Engineer

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.

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.

Requirements:

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).

Reports to:

QA Manager