Quality Engineer (Design Control)

Job Title: Quality Engineer I -(Design Control)Location: Lake Forest, CA - onsiteContract Length: 6 months with potential to be extended About the RoleIn this role, you will work closely with R&D, Regulatory, Operations, and other cross-functional stakeholders to provide hands-on quality engineering support across the product development lifecycle. You will contribute to key activities such as design controls, risk management, verification and validation, supplier-related quality support, change control, and product transfer.Top skills:VMV reports must haveDesign plan and user requirement or Design Control exp required.Design study and development are a must have skill.New product development exp is required.ISO 14971 understanding is must.Review the protocol and the sample size / design.Major Accountabilities:Provide hands-on quality engineering support for new product development projects and design changes to existing instrumentation productsEnsure quality requirements are appropriately applied throughout development, documentation, verification, validation, and transfer activitiesPartner with project teams to provide practical quality guidance, technical assessment, and risk-based decision support that helps keep development activities moving forwardReview and approve design control deliverables, including risk management files, verification and validation documentation, and related development recordsEvaluate product and process changes for quality and regulatory impact, and support change control activities from assessment through implementationPartner with cross-functional teams to investigate deviations, support root cause analysis, and drive corrective and preventive actions as neededMaintain compliance with applicable GxP requirements, standard operating procedures, and documentation practices Minimum Qualifications:Bachelor’s degree in engineering, life sciences, or a related technical field2+ years of quality engineering experience in the medical device industry, including direct support of instrumentation or electromechanical product development in an ISO 13485 environmentExperience with design controls, change control, and product impact assessmentsWorking knowledge of applicable medical device quality system and regulatory requirements, including ISO 13485, design controls and GxP principlesAbility to work effectively across global, cross-functional teams, communicate clearly with technical and non-technical stakeholders, and contribute with minimal ramp-upExperience with risk management in accordance with ISO 14971Experience reviewing or supporting verification and validation protocols, reports, and related documentationPreferred QualificationsStatistical knowledge to support sample size determination and the design of verification and validation studiesWorking knowledge of applicable product and safety standards, such as the IEC 60601 series and ISO 14971ASQ Certified Quality Engineer (CQE) certificationSix Sigma Green Belt or higherStrong communication, organization, collaboration, and independent problem-solving skillsEEO:“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”