Design Assurance Quality Engineer

Job Title: Design Assurance Quality Engineer

Location: Irvine, CA

Experience: 6+ Years

Duration: 12+ months contract

Job Summary

This role centers on making sure new medical device products meet the highest standards of quality, safety, and compliance from early design through final release. You’ll guide design controls, drive risk management, support verification and validation, and work closely with cross-functional teams to keep development on track and aligned with regulatory expectations.

Responsibilities

• Develop quality assurance documentation to support new product development and regulatory submissions

• Maintain and improve quality system processes by identifying gaps and correcting deficiencies

• Contribute to design development manufacturing and risk management activities across NPD projects

• Participate in design reviews identify product risks and ensure mitigation strategies are sound

• Support creation of design verification and validation test requirements

• Prepare final verification and validation reports including statistical and graphical analysis

• Promote efficient testing methods and assist in developing manufacturing processes for new products

• Use statistical tools and problem-solving methods to establish acceptance criteria and resolve quality issues

• Develop review and approve inspection plans routers and product drawings for new designs

• Support design transfer activities to manufacturing sites

• Evaluate predicate products to identify quality issues relevant to new development

• Define critical quality attributes through structured risk analysis

• Gather and assess initial market feedback and address early concerns

• Lead risk management efforts including developing risk plans and conducting risk reviews

• Essential Skills

• Hands-on experience with the medical device product development lifecycle

• Strong knowledge of risk management and design/process verification and validation

• Working knowledge of advanced quality tools FMEA GD&T RCA Mistake Proofing

• Ability to read and interpret CAD drawings

• Experience interacting with regulatory agencies including FDA MoH TUV

• Knowledge of US and international medical device regulations

• Familiarity with CAPA audits and statistical quality concepts

• Solid project management capability and ability to juggle multiple priorities

• Strong communication interpersonal and negotiation skills

• Strong analytical critical thinking and independent problem-solving ability

• Experience handling compliance and risk situations

• Proficiency with analysis software such as Minitab

• Additional Skills

• Ability to advocate for product quality throughout the development process

• Comfortable working cross-functionally with Operations R&D RA Marketing and others

• Demonstrated success managing and completing projects within a matrix environment