Senior Quality Engineer

Senior Quality Engineer (Complaint Investigation)Location: Irvine, CA (100% Onsite)Duration: 12+ Months ContractPay Range: $45.00/hr - $60.00/hrJob DescriptionThe main function of a Sr Engineer in this quality role is to focus on implementing and optimizing quality engineering practices related to Complaints Investigation, Post Market Surveillance and Risk Management while ensuring a culture of quality and compliance with global regulatory requirements.Education and Experience5-7 years of experience required.SkillsProven expertise in the usage of MS Office Suite including MS Project; Electronic Quality Management System. Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skillsBasic understanding of statistical techniquesTeam player and detail-oriented.Substantial understanding and knowledge of principles, theories, and concepts relevant to EngineeringStrong problem-solving, organizational, analytical and critical thinking skillsSubstantial understanding of processes and equipment used in assigned workGood leadership skills and ability to influence changeKnowledge of applicable FDA regulations for the medical device industryStrict attention to detailAbility to interact professionally with all organizational levelsAbility to manage competing priorities in a fast-paced environmentMust be able to work in a team environment, including inter‑departmental teams and key contacts representing the organization on contracts or projectsAdhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence/controlJob ResponsibilitiesInvestigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) based on engineering principles; analyze results, make recommendations and develop reports.Execute complaint investigations multifunctional approach and address issues addressed in a systematic, methodical manner.Lead Post Market Surveillance activities for products approved in the EU.Oversight of all complaints that require investigation through the different phases.Ensure on-time completion of complaints.Work closely with complaint investigation owners to resolve issues and ensure those that have passed their due dates are addressed.Ensure complaint investigations are adequate and comply with applicable procedures.Develop, update, and maintain technical content of risk management filesOther incidental duties assigned by LeadershipSeniority LevelMid-Senior levelEmployment TypeContractIndustryMedical Equipment Manufacturing#J-18808-Ljbffr