POSITION SUMMARY: Provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes. Support supplier quality issues impacting daily operations. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Ensure compliance to regulation and standards.
GENERAL REQUIREMENTS: Previous industry experience desired.Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.Understanding of US and International Medical Device Regulations.Familiarity with ISO 13485, GDP, GMP desired.Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.Ability to represent Quality function with project teams.Strong interpersonal skills, written, oral communication and negotiations skills.Strong in critical thinking and "outside the box" thinking.Highly developed problem solving skills. Strong analytical skills.Demonstrated ability to work independently and as part of cross-functional teams.Experience in working in a compliance risk situation.Computer literacy.Some travel may be required.KEY AREAS OF RESPONSIBILITY: Work closely with operations and the business functions to ensure quality performance of product and processes.Collaborates with Divisional QA, cross-functional and suppliers' teams to address top quality issues.Own identified internal and supplier driven non-conformances and manage the timely closure of NC's within Trackwise. Own or support identified internal CAPAs and manage to timely root cause investigation, implementation and closure.Disposition non-conforming product within MRB, issuing NC's as appropriate.Communicate & collaborate with suppliers regarding non-conformances, escalating supplier corrective action requests as required.Engage in the development and improvement of the internal manufacturing processes for existing products.Performs critical assessment of internal and supplier proposed change management activities.Performs PPAP activities for supplier changes.Participates and may lead in the creation and/or review of new or modified procedures.Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.Support execution and analysis of manufacturing related complaints and product field actions.Support and Drive Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification.Develop understanding of risk management practices and concepts and applies knowledge to manufacturing operations.Support the creation and maintenance of inspection methods and sampling.Applies statistical methods of analysis and process control to current operations.Engage and interface in internal and external audits providing subject matter expertise.Support the development and review of process and equipment validation/qualification and MSA of internal processes.Execute internal quality deliverables associated with engineering changes, manufacturing transfers and supplier-initiated changes.Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.Responsible for initiation, internal containment, communication and support of Commercial Holds for potential product escapes.QUALIFICATIONS KNOWLEDGE SKILLS: BS in a science, engineering or related discipline.MS, CQE, or CRE preferred.Six Sigma Green or Black belt preferred.Minimum of 3 years' experience preferred.
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