Design Quality Engineer II

Actalent•Irvine, CA

27d•$50 - $55•Onsite

About The Position

As a Design Quality Engineer II, you will play a crucial role in ensuring the quality and compliance of new medical device products throughout their development lifecycle. You will be responsible for supporting the design control process, conducting risk management activities, and engaging in design reviews to ensure product excellence and adherence to regulatory standards.

Requirements

Experience with the medical device product development lifecycle, including risk management and design/process verification and validation.
Applied knowledge of Advanced Quality tools such as FMEA, GD&T, Root Cause Analysis, and Mistake Proofing.
Ability to read and interpret CAD drawings.
Experience interacting with regulatory agencies such as FDA, MoH, TUV.
Thorough knowledge of US and International Medical Device Regulations.
Strong knowledge of Quality Concepts like CAPA, Audits, Statistics.
Strong project management skills and the ability to manage multiple tasks simultaneously.
Strong interpersonal, written, oral communication, and negotiation skills.
Critical thinking and problem-solving skills.
Analytical skills and the ability to work independently.
Experience in compliance risk situations.
Proficiency with computer literacy, including analysis programs like Mini-Tab.

Nice To Haves

Demonstrated ability to advocate for product excellence and quality.
Ability to work cross-functionally with departments such as Advanced Operations, Product Development, Regulatory Affairs, and Marketing.
Demonstrated ability to manage and complete projects in a matrix organization.

Responsibilities

Develop quality assurance documentation to support new product development and regulatory submissions.
Maintain quality system processes by identifying and correcting deficiencies in procedures and practices.
Engage in design, development, manufacturing, and risk management activities for new product development projects.
Participate in design reviews by identifying product risks and ensuring effective mitigation strategies.
Support the definition of design verification and validation test requirements.
Complete final design verification and validation reports with statistical and graphical support.
Promote efficient testing practices and support the development of manufacturing processes for new products.
Utilize statistical analysis and problem-solving techniques to establish product acceptance limits and resolve quality issues.
Develop, review, and approve inspection plans, routers, and product drawings for new products.
Support product design transfers to manufacturing facilities.
Evaluate predicate products for relevant quality issues impacting new development projects.
Analyze and define critical quality attributes through risk analysis techniques.
Participate in the collection of initial market feedback and address early concerns.
Lead risk management activities by developing risk management plans and conducting risk reviews.