Quality Engineer

Manage Corrective and Preventive Actions (CAPA) process and assist owners with quality issues/nonconformances across all Caerus Corp. business units to execute the CAPA process in a compliant and timely manner. Support CAPA owners through CAPA phases and ensure they follow the CAPA process and deliver solid quality records of their actions. Work closely with issue identifiers and owners to assess whether new product or quality system issues will escalate to CAPA investigation. Prepare reports and/or necessary documentation (i.e., CAPA) and provide support to applicable stakeholders, both internal and external. Support customer and/or patient complaint investigations and complete required documentation. Participate in audit and inspection preparation, resolution of audit and inspection findings and liaise with auditing groups and inspectors through all stages of the audits. Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations. Assist in legal requests in support of government investigations or litigations. Ensure the quality assurance programs and policies are maintained and modified regularly. Perform statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Collect and analyze process defect data for product/process improvement efforts (e.g. scrap, nonconforming product, customer/patient complaints. Evaluate the adequacy and compliance of systems, operations, and practices against regulations and company documentation. Utilize quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root cause analysis, reading and correcting process documents. Support product/process validation, design change and review, quality planning, and risk evaluation. Support engineering, production, and various business unit projects in document control practices. Participate in Continuous Improvement Projects (CIP) for both process and business systems. Participate in the development of a company-wide safety program. Participate in the development of a company-wide training program of the QMS. Bachelors degree in Engineering, Science or technical field required. Minimum of 3 years of related experience in quality assurance (medical device industry preferred). Working knowledge of Quality System Regulation (QSR 21 CFR 820), and ISO 13485:2016. Strong verbal and written communication skills. Must be comfortable working in an environment with animals. Proficient in use of computer systems and software: Microsoft Word and Excel (charts, graphs, macros, logging, tracking/trending data), PowerPoint presentations, Adobe Acrobat. NetSuite ERP/MRP experience preferred. Compensation and Benefits: Medical, dental, vision, basic life, voluntary life and A&D, holiday pay, paid time off, bi-annual performance bonus. Exempt: $70,000 - $90,000. DOE