Quality Engineer

One of our clients, a growing manufacturing company in Greenville, SC is seeking a Senior Quality Engineer to join their team! The role of the Senior Quality Engineer is to work with engineering, process, and manufacturing personnel to develop specifications, processes, and procedures that will ensure products meet or exceed customers’ expectations. The Senior Quality Engineer will organize all major components of the QMS including change control, process control, calibration, and CAPA through feedback. This is also a leadership opportunity to supervisor a team of three Quality Inspectors in daily activities.Responsibilities:Responsible for supervision of QA Inspectors / Technicians (in-process and outgoing quality). This includes the review of associated records.Quality Assurance Inspectors:Performs inspections and tests for incoming, in-process, and finished products. Serves as authority for the release of Class II Devices for further distribution. Performs complaint investigations and service on returned products. Maintains records, including files of device history records.Administrates the internal audit program and vendor approval.Assist with the coordination of activities relative to corrective and preventive action.Assist in maintaining QA files of quality records – document control.Performs routine audits of the preventive maintenance program and other internal audits as assigned.Responsible for assisting in the coordination and administration of Engineering Change Orders from engineering to manufacturing for both new products and changes to existing products.Assist in ensuring that all activities relative to the engineering change are performed, documented, and records maintained - regulatory requirements, process capability/control, quality plans, etcPerforms trend analysis for complaints and other quality indicators including quality objectives.Responsible for the calibration programSet up proper instrumentation to measure and record variables and train employees on the proper use of the instruments.Establish Process Control PlansInterface with product development, manufacturing, process, and quality personnel as well as with Span America sales and marketing to determine product quality specifications.Provide all necessary information concerning product parameters and inspection to production personnelEvaluate processes and ensure they are capable of consistently meeting specification requirementsDefine attributes and sets accept/reject parametersAssist in developing effective corrective actions to quality issuesAssist with returned product investigations as needed to understand failure modes and actions required.Assist with handling customer complaints and service requests.Assist with various Regulatory Activities:Develop regulatory strategies for product development and launch of new products.Ensure that US and other international regulatory requirements are incorporated as part of the development process.Assist or lead the preparation and maintenance of moderate-complexity regulatory submissions while maintaining quality standards.Prepare responses to standard questions and comments from regulatory agencies and ensure issues are addressed in a timely manner.Understand regulatory processes, guidelines and guidance documents and what they mean to the organization and ensure that they are communicated through regulatory procedures.Maintain facility and product registrations and licenses with various regulatory bodies.Establish and maintain Technical Files as applicable.Compile and maintain regulatory documentation databases or systems.Establish an effective Statistical Process Control ProgramWilling to travel internationally to internal and external customers to resolve quality problems and build effective customer relationships.Requirements:Bachelor’s degree in an engineering, health science or related field preferred.5+ years’ experience as a Quality Engineer in the medical device industry.If degree is not in Engineering or a Health Science field, 10+ years of Quality Engineer or Medical Device Regulatory experience required.Lead ISO 13485 Auditor certification preferred.Ability to understand and utilize basic statistical analysis.Ability to perform root cause analysis and corrective action.Ability to understand and utilize fundamental gauge validation and calibration.Demonstrate knowledge of product fitness for use that meets or exceeds customer expectations.Demonstrates thorough understanding of auditing systems.Ability to develop and maintain processes that are ISO, MDSAP, and FDA compliant.Ability to utilize failure mode and effects analysis.