Quality Engineer

Title: Senior Quality Engineer / Quality Engineering ConsultantLocation: UtahWork Arrangement: 100% onsiteEmployment Type: Contract / ConsultingAbout this positionWe are seeking a Senior Quality Engineer / Quality Engineering Consultant to provide hands-on quality leadership and technical support within a medical device manufacturing environment.This is an excellent opportunity for a senior-level Quality Engineer who can hit the ground running, take ownership of complex quality investigations, reduce investigation backlogs, strengthen manufacturing controls, and help stabilize a high-risk medical device product line.Key ResponsibilitiesProvide senior-level quality engineering support and technical guidance to a developing Quality team.Assess current quality processes, team capabilities, and areas requiring improvement.Lead and support investigations involving nonconformances, SCARs, audit findings, customer complaints, and manufacturing issues.Drive investigations beyond simple "operator error" conclusions to identify systemic root causes and effective corrective actions.Develop and implement appropriate process controls and containment strategies to stabilize manufacturing operations.Support the resolution and closure of a significant backlog of quality investigations and documentation.Apply structured root cause analysis, CAPA, and continuous improvement methodologies.Support manufacturing processes including molding, extrusion, gluing, welding, tipping, over molding, assembly, packaging, and labeling.Investigate issues involving exposed wire, cold braid, tipping flash, sealing, labeling, sterilization, line clearance, and other manufacturing defects.Partner closely with Manufacturing Engineering to evaluate equipment-related issues and determine appropriate process and quality controls.Support process validation, equipment qualification, and validation activities associated with process or equipment changes.Utilize quality data and statistical methods, including SPC, to monitor and improve manufacturing processes.Work with both internal and external suppliers on quality issues, investigations, and SCARs.Manufacturing EnvironmentThe facility manufactures high-risk medical devices used in cardiac procedures. Products are vertically integrated and may involve:Plastic molding and extrusionTubing and reinforced tube constructionTippingWelding and bondingGluingOver moldingAssemblySealingPackaging and labelingThird-party sterilizationRequired QualificationsBachelor's degree in engineering, Quality, or a related technical discipline.Strong experience as a Quality Engineer in a regulated medical device manufacturing environment.Senior-level experience leading quality investigations and resolving complex manufacturing issues.Strong knowledge of root cause analysis, nonconformance investigations, SCARs, CAPA, and audit remediation.Experience with process validation and equipment qualification.Experience working with manufacturing processes such as molding, extrusion, welding, bonding, gluing, or assembly.Strong understanding of medical device quality systems and regulated manufacturing practices.Experience using SPC/statistical analysis to evaluate and control manufacturing processes.Ability to work independently and provide technical leadership to a developing team.Strong written and verbal communication skills.Comfortable interacting directly with customers and serving as the quality representative for a product line.Demonstrated ability to quickly assess problems, establish priorities, and drive issues to resolution.Preferred QualificationsPrevious leadership, mentoring, or manager-level Quality Engineering experience.Experience in a contract manufacturing environment.Experience supporting high-risk or Class II/III medical devices.Supplier quality and SCAR experience.Experience with manufacturing process improvement and error-proofing.Lean/Six Sigma or similar continuous improvement experience.