Quality Engineering Techs

Quality EngineerRiverpoint Medical in Portland Oregon is looking to hire a Quality Engineer. At Riverpoint you will be part of the process that brings great technology to Medical, Dental and Veterinary markets. We specialize in the design and manufacturing of premium medical devices. The Riverpoint Quality Engineer (QE) is responsible for driving proactive improvements to quality systems and processes. The QE will work with production to support quality assurance, manage and resolve non-conformities, validate processes, resolve customer issues, and continually improve the quality system.Duties and Responsibilities:May provide oversight and ensure timely execution of the complaint handling processMay responsible for all complaint analysis activities and trending.May collaborate with Regulatory on Medical Device Reporting (MDR) and adverse event reporting requirementsCoordinate planning, implementation and trending of multiple quality management systems including CAPA, SCAR, and non-conformances.Perform internal and supplier auditsAssist in the writing and execution of system validation plansPromote compliance to company proceduresSupport process validation studies for special processes and drive a reduction in Riverpoint Medical's reliance on inspection/verification as a quality assurance methodologyDevelop and execute IQ, OQ and PQ protocols for product, processes, and equipment within the facilityWrite reports summarizing results and statistics for all equipment, product, or process validation projects. Assist production with equipment installation and maintenanceImprove upon process controls related to Finished Device packaging, labelling and sterile product management, including aspects such as label reconciliation, segregation and material flow controls, and lot release activitiesParticipate in the timely processing of complaints, non-conformity, returned materials and corrective actionsAssist in investigations of incidents related to Riverpoint Medical products and appropriate reporting of such events to US and foreign regulatory authorities and notified bodies, as applicableAssist in QA/RA, production and product development personnel in formatting and compiling quality system documentsEducation and Qualifications BS (engineering preferred) with 3+ years related experience in the medical device industry or MS engineering and 0+ years related experience, or equivalent experienceComplaint analysis activities and product failure investigations desirableCAPA planning and implementation desirableUse of Failure Mode Effects Analysis (FMEA) desirableWork experience in an ISO13485 or FDA regulated environment desirableComputer skills, including Word and ExcelDemonstrated technical writing skillsWe offer great benefits: Medical, Dental and Vision, Life and Accidental Death Insurance; 401(k) with company match and immediate vesting, Paid Time Off and 8 company paid holidays.Riverpoint Medical is committed to a diverse and inclusive workplace. Riverpoint Medical is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.