Quality Engineer III

Company Introduction: We partner and innovate with our customers to provide the highest quality life enhancing medical devices in the : Medical dental and vision benefits-effective on date of hireGenerous paid time off benefits and 10 paid Holidays136 Hours PTO (prorated based on hire date)Company-paid life insurance401k plan with company matchWell-Being:Low-cost nutrition and mental health visitsUp to $150-off your gym membership annuallyDiscounted Pet Insurances for your furry friendsAccess to individualized financial planning meetingsEmployee Discount Program with savings on electronics home goods gym equipment and moreDiscounted family caregiving supportCareer Growth:Tuition ReimbursementOn-site Training ProgramsDefined Career Path for advancement in role and compensationNew Hire On-boarding Training PlansOur top-notch work environment includes:Climate & Comfortable SettingDescription: The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance. Independent contributor. Responsibilities:Adheres to Viant Core Beliefs and all safety and quality requirements including but not limited to: Quality Management Systems (QMS) Environmental Management Systems (EMS) U.S. Food and Drug Administration (FDA) regulations Company policies and operating procedures and other regulatory regulatory and agency inspections audits investigations and inquiries regarding the control and assessment of product design and manufacturing manufacturing of assigned products assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are various product and process improvement the adequacy and correctness of changes to Bill of Materials (BOMs) Assembly Procedures Drawings Component Specification FMEAs Control Plans risk protocols and reports for test method with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing approval and implementation of Incoming In-Process and Final Inspection that the disposition of non-conforming materials meets all necessary regulatory requirements and assures the adequacy of corrective actions to prevent communicates and interacts with complaint plant CAPA activities including analysis of data and trends in complaints supplier quality nonconforming material training effectiveness and root causes with product with suppliers management Engineers and Manufacturing associates in the resolution of quality problems. Also executes capability studies and applies statistical quality control which includes Cpk DOE Hypotheses Testing the preparation of Quality Plans including inspection test and gauge requirements for new product support to other quality a heavy workload while maintaining potential roadblocks and provides innovative with a high level of integrity and to and accountable for achieving goals and raw material in-process most gauging a working knowledge of GD& in executing capability studies and test method OGP and/or CMM to support automated in complaint investigations and CAPA training (e.g. Inspections and Calibration).Leads in performing calibration activitiesPerforms other functions as :Knowledge/Education:Bachelors Degree preferred in Engineering or related field required or 5 years of experience working in a quality engineering role within a regulated industry. Experience: Minimum 5 years experience at Quality Engineer level II in medical device or regulated Ability to multitask and drive initiatives to completion Competence in the selection and use of Quality Engineering Tools and Techniques. Strong communication skills and ability to align with key stakeholders Strong working knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. FDA 21CRF820 ISO 13485:2016; MDSAP; ISO14971 QSR MDD TGA etc.) Proficient in Microsoft Office and Minitab Physical: Light physical activity performing non-strenuous day-to-day activities of an administrative lifting (20 lbs.) carrying (10 lbs.) bending pushing/pulling crawling climbing balancing and prolonged dexterity sufficient to reach and handle items. Requires the ability to identify and distinguish colors judge distance and space relationships (i.e. visualize objects of multiple dimensions) and adjust the lens of the eye to bring an object into sharp focus (microscope etc.).