Senior Manager, Quality Engineer

POSITION : Senior Manager, Quality EngineeringFULL-TIME/PART-TIME : Full TimeLOCATION : Bothell, WAGENERAL SUMMARYThe Senior Manager Quality Engineering provides resource to support New Product Development, Design Transfer, Manufacturing and Sustaining of commercialized product including Receiving Inspection.QUALIFICATIONS7+ years of experience or equivalent experience in Medical Device Design control and the application of ISO14971, 21CFR820, ISO13485, IEC62304, IEC 62366, IEC 606015+ years or equivalent experience as a people manager.Experience with new design, design transfer, manufacturing and sustaining of electro-mechanical and software driven devices.Experience with Test Method Validation, Design Validation, Design Verification and Process ValidationExperience with Risk Management file creation (use, design and process) and maintenanceExperience with Control PlansExperience with Inspection Specification creation and Receiving Inspection executionBachelor's in EngineeringPreferred EducationMaster's in EngineeringPreferred ExperienceExcellent attention to detail and project management skills.Excellent written/oral communication skills. Must be able to work effectively with diverse groups of people.Physical DemandsRequires normal visual acuity and hearing.Typically, employees sit comfortably to do their work, interspersed by brief periods of standing, walking, bending carrying papers and books, and extensive periods requiring the use of computer terminals to accomplish work objectives.Required to sit and use their hands and fingers to handle or feel and manipulate keys on a keyboard.Additional skills may be required to perform additional task(s) specific to work location, department or line of business.Working ConditionsPredominantly operates in an office environment and research and development laboratory as requiredDUTIES AND ESSENTIAL FUNCTIONSAbility to review and approve changes to currently commercialized product w.r.t. the use, design and process risk management of the product.Manages Design Quality, Manufacturing Quality and Quality Control (Receiving Inspection) resources and processes.Applies statistics to make business decisions.Ability to conduct failure investigation and root cause analysis.Must be able to work in lower maturity processes using critical thought to provide pathways for business continuity and improve the systems.Ability to manage remote employees, effectively and efficiently.Coordinate and work closely with other engineering, logistics, financial, and program management disciplines to define system specifications and requirements.Attends and participates in departmental meetings.Attends seminars and training sessions necessary to maintain appropriate level of professional competence.Ensures all department compliance guidelines are met.Attends all meetings, in-services training, or continuing education as delegated by the supervisor.Provides customer focused interactions.Performs all duties necessary for the department as per department policies and procedures.Performs other duties and responsibilities as delegated by the supervisor within the scope of practice and the responsibilities in the department.Pay Range: $150,000 - $165,220 per yearCareer Management Group is a boutique staffing partner focused on meaningful placements across healthcare, life sciences, technology, professional services, and more. Every role we represent is carefully vetted and client-approved — our goal is to match you with an opportunity where you can truly thrive.