Quality Engineer

Quality EngineerWe are looking for a hands-on Quality Engineer to support and improve quality systems within a regulated manufacturing environment. This person will own CAPAs, investigations, process controls, validations, risk management, and quality data, while partnering closely with Manufacturing, Engineering, and Operations. The ideal candidate has personally implemented or improved quality processes, can investigate problems from root cause through corrective action, and can speak in detail about the work they have owned.Compensation: $110-130k. Exact compensation may vary based on several factors, including skills, experience, and education. Employees in this role will enjoy a comprehensive benefits package starting on day one of employment, including options for medical, dental, and vision insurance. Eligibility to enroll in the 401(k) retirement plan begins after 90 days of employment. Additionally, employees in this role will have access to paid sick leave and other paid time off benefits as required under the applicable law of the worksite location.Required Skills & Experience1. CAPA + Investigations3+ years Quality Engineering experienceHands-on ownership of CAPAs and nonconformance investigationsStrong root cause analysisAble to take corrective actions through implementation and effectiveness checksProcess Controls + Quality SystemsExperience in regulated manufacturing, ideally medical deviceISO 13485 / FDA quality system experienceProcess controls, process definition, and quality dataMust have personally implemented, changed, or improved a quality processValidation + RiskExperience with IQ/OQ/PQ and process validationRisk management / FMEAComfortable analyzing quality trends and manufacturing issuesNice to Have Skills & ExperienceMedical device experienceISO 14971 / Risk ManagementNPI / design transfer experienceSPC / MSA / MinitabLean / Six SigmaCleanroom experienceASQ Certified Quality Engineer (CQE)Audit experience