Quality Engineer

Quality EngineersR&L Spring Company and Medicoil are both seeking Quality Engineers. Location: Lake Geneva, WI Company: R&L Spring Company and Medicoil Compensation: $85,000 + About the Role: R&L Spring Company and Medicoil are both seeking Quality Engineers.The Quality Engineer reports to the Quality Manager and is responsible for supporting and improving the Quality Management System (QMS) through analysis, auditing, problem-solving, and continuous improvement initiatives. This role partners closely with Engineering, Manufacturing, Suppliers and Customers to investigate quality issues, implement corrective actions, reduce risk and ensure compliance with applicable quality standards and customer requirements.This position supports both internal and external quality initiatives, including audits, validations, supplier quality, process improvement and new product development activities within a manufacturing environment.Duties/ResponsibilitiesSupport and coordinate internal, customer, and certification audits of the Quality Management System (QMS)Assist in maintaining compliance with ISO 13485:2016, ISO 9001, and/or IATF 16949 requirementsRecommend improvements to align company procedures with quality standards and customer requirementsSupport and lead internal audit activities according to established schedulesCoordinate and conduct layered process audits, product audits, and manufacturing process auditsDevelop and maintain quality documentation including procedures, work instructions, inspection plans, control plans, and process flow diagramsCreate and support PFMEAs, risk assessments, acceptance criteria, and quality validation plansPerform root cause investigations and lead corrective and preventive actions (CAPA/CAR/PAR)Analyze non-conformances (NCRs) and work cross-functionally to implement effective corrective actionsInterface directly with Engineering, Manufacturing, Document Control, Suppliers, and Customers regarding quality-related issuesSupport supplier qualification activities, supplier assessments, and Approved Supplier List (ASL) managementAssist with Production Part Approval Process (PPAP) activities including dimensional layouts, SPC, MSA, process controls, and supporting documentationPerform inspections, product layouts, testing reviews, and data analysis as requiredSupport validation and verification activities including IQ/OQ/PQ and process validationIdentify process and product risks and support continuous improvement initiativesAssist in quality planning activities for new product development and manufacturing processesDevelop training recommendations and support quality-related employee training activitiesEnsure accurate and timely reporting of quality data and documentationSupport quality assurance and quality control activities throughout the organizationPerform additional duties as assigned by Quality ManagementRequired Skills/AbilitiesStrong understanding of quality systems, manufacturing processes, and continuous improvement principlesWorking knowledge of ISO 13485, ISO 9001, IATF 16949, GMP, and quality assurance methodologiesExperience with AIAG Core Tools including PFMEA, Control Plans, SPC, MSA, and PPAPAbility to read and interpret engineering drawings, blueprints, GD&T, and technical specificationsStrong problem-solving, analytical, and root cause analysis skillsExcellent organizational skills and attention to detailEffective written and verbal communication skillsAbility to work effectively in a fast-paced manufacturing environmentProficiency with Microsoft Office applicationsProject management and cross-functional collaboration experience preferredKnowledge of validation and verification processes including IQ/OQ/PQ preferredEducation and ExperienceEngineering degree or equivalent combination of education and experience preferredMinimum 2 years of quality engineering or quality systems experience in a manufacturing environmentExperience with medical device and/or automotive quality systems preferredAuditor certification or auditing experience preferredExperience with wire forming, plating, coatings, or metal manufacturing processes is a plusCertified Quality Engineer (CQE) certification preferredPhysical RequirementsProlonged periods of sitting and working on a computerAbility to occasionally lift up to 50 poundsAbility to work within a manufacturing environment as neededWork LocationThis position is fully onsite in Lake Geneva, WI and requires daily in-person attendance in a manufacturing environment.