Quality Engineer

Job 2705 - Quality Engineer - Contract located in Los Angeles CountyMedical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.Applicants must be authorized to work in the U.S. in accordance with applicable law. This position is not eligible for employer-sponsored work authorization now or in the future.OnsiteAbout This RoleResponsible for creating test methods work instructions, training and mentoring technicians who work on investigation of return and not-return products. The QE will review results of investigations completed by others for accuracy, completeness and compliance to SOPs/WIs. The results of investigations can be used to escalate product issues in collaboration with other Post Market functions R&D, Design Assurance, Operations, Supplier Management and Medical Safety.Your Responsibilities Will IncludeUnderstanding failure modes and approving product analysis for return and non-return complaints related to mechanical medical devices performed by techniciansCoordinating training and supervising failure investigation activities for lab techniciansSupport integration of new products into CIS lab by creating/validating test methods and test instructionsCreating and presenting slides for SER/CRBCollaborating with other Post Market CCC/CMC teams, R&D, Design Assurance, Manufacturing, Supplier to help determine root cause of complaintsMonitoring product performance and escalating any non-conformance issues with returned devicesCreating, releasing new WI/SOPs in document control systemInitiating and owning non-conformance investigationsTraining technicians to find root cause of complaints through sound failure analysis techniquesMinimum QualificationsWhat We're Looking for in You: Bachelor's degree in Mechanical Engineering with 2 years of relevant experienceBachelor's degree can be in electromechanical/electrical, but the candidate needs to have hands-on experience in failure analysis.Demonstrated problem-solving, failure analysis, capabilities of mechanical systems/componentsProficient with Microsoft Office tools including Word, Excel, PowerPoint and OutlookGreat written/verbal communication skills and ability to collaborate with other teamsAbility to successfully multi-task and be adaptivePreferred QualificationsMasters degree in Mechanical Engineering with at least 1 year experience in similar roleAbility to understand system level functionalities to devise and validate test methods for failure analysis of systems/componentsExperience in Medical Device industry - Familiarity with Post Market requirements and systemsFamiliarity complaint systems used for medical devicesExperience with using SAP and PowerBIMEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Medical Engineering Consultants (MEC) and will not be obligated to pay a placement fee.Sponsorship is not available for this positionCheck us out at www.medicalengineeringconsultants.comAAP/EEO DFWPReasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Other DutiesPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.