You wonāt just maintain quality systems; youāll actively improve them.________________________________________What youāll be doingā¢āāāāāDevelop and improve quality processes that ensure products meet customer and regulatory requirementsā¢āāāāāCreate and maintain documentation such as SOPs, work instructions, control plans, PFMEAs, and inspection reportsā¢āāāāāAct as the primary point of contact for customer validation activitiesā¢āāāāāPartner with Engineering and Operations to drive IQ/OQ/PQ and/or PPAP validation effortsā¢āāāāāLead root cause investigations and CAPA activities using structured methods like 8D, 5 Whys, and Fishboneā¢āāāāāSupport inspections, calibrations, audits, and production validationsā¢āāāāāMonitor process performance, identify issues, and ensure corrective actions are implementedā¢āāāāāAnalyze quality data and provide insights that drive real improvementsā¢āāāāāLead Material Review Board (MRB) activities and manage nonconforming materialsā¢āāāāāWork cross-functionally to continuously improve processes and reduce defects________________________________________What weāre looking forā¢āāāāā2ā4 years of experience in a manufacturing environmentā¢āāāāāFamiliarity with ISO 9001 and/or ISO 13485ā¢āāāāāStrong problem-solving skills and attention to detailā¢āāāāāExperience with measurement and inspection techniquesā¢āāāāāComfortable working with data and drawing meaningful conclusions (Minitab is a plus)ā¢āāāāāOrganized, self-driven, and able to manage multiple priorities in a fast-paced environmentā¢āāāāāStrong communication skills and ability to work across teamsNice to haveā¢āāāāāExperience with IQ/OQ/PQ or validation processesā¢āāāāāISO auditing experience or certification________________________________________What to expectThis role is a mix of desk work and time on the manufacturing floor. Weāre looking for a Quality Engineer who enjoys solving problems, improving processes, and working closely with both engineering and production teams.