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Senior Quality Engineer

Company: Bioventus, LLC
Location: Chapel Hill
Posted on: November 2, 2019

Job Description:

Senior Quality Engineer sought by Bioventus, LLC in Durham, NC. 40 hours/week.Duties: Ensure regulatory requirements (e.g. design control) and process/product goals (e.g. process capability) are met utilizing project/process planning and execution skills. Work with multiple project schedules and manage competing priorities. Identify specification needs/requirements and assist with the creation and/or modification of specifications. Support design transfer activities focused in development of gage design, inspection processes, GR&R, capability studies and process validation. Facilitate design review activities of new products and work closely with product design teams to ensure quality considerations during all Stages of product development. Provide guidance and help solve significant or chronic process or product problems. Discuss customer problems with marketing and sales as needed. Generate, analyze, and present reports on quality related key performance indicators (KPI) such as line yields, final release, supplier performance and customer experiences to internal product improvement teams. Support quality systems such as delivery holds, internal and external audits, CAPA and investigations. Track direct supplier quality and performance. Manage and track non-conformance reports and CAPA review board meetings. Perform root cause analysis and assign corrective actions. Become SME for sterilization processes. Create the Bioventus organizational processes and systems to support the financial reporting and analysis and stage gate/product launch on schedule. Align direct and non-direct resources to support the systems and processes on an ongoing basis. Coach and manage performance of reports, ensure focus on functional and company objectives. Ensure adherence to budget standards and guidelines.Minimum Requirements: Bachelor's degree in a biomedical engineering discipline and 5 years (with bachelor's) or 3 years (with master's) of experience working within the medical device industry. Must have the understanding of, and ability to interpret, regulations and guidelines governing medical devices including ISO 13485 and 21 CFR 820.Skills: a minimum of 5 years' experience in the following areas with bachelor's or a minimum of 3 years' experience with master's: interacting directly with suppliers, manufacturing, and manufacturing support organizations. Applying quality engineering concepts such as process capability analysis, risk assessment, PFMEA and DFMEA. Applying quality assurance and control tools (Statistical Analysis, DOE, Gauge R&R and SPC). Data analysis and critical thinking skills. Technical writing in the form of protocols and reports. Ability to present complex technical data to employees at all levels of the organization. Knowledge of process and product development and validation methodologies (IQ, OQ, PQ). Design control in a regulated industry for sterile medical devices.--
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Keywords: Bioventus, LLC, Chapel Hill , Senior Quality Engineer, Other , Chapel Hill, North Carolina

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