Senior Quality Engineer

🚨 Immediate Need — High-Impact 11-Month Engagement with a Leading Orthopedic Device CompanyStrictly W2 Only - No C2CJob Title: Quality Senior Engineer I — CAPA & Compliance Location: Englewood, CO 80112 - Locals Only | Onsite Duration: 11-Month Contract Rate: $52/hr — W2 Only⚠️ SUBMISSION NOTES: W2 engagement only — No C2C or 1099 | Local Colorado candidates only | Please include availability for prescreen when submitting.📞 2-3 Time slots for pre-screening are required at the time of submission.WHAT YOU WILL DO → Review, remediate, and migrate legacy CAPA records into EtQ — ensuring completeness, accuracy, and compliance with global procedures → Manage assigned CAPAs end-to-end: initiation, investigation, action tracking, effectiveness verification, and closure → Perform gap assessments on CAPA records and correct documentation deficiencies to meet regulatory and internal QMS standards → Partner cross-functionally with Quality, Regulatory, Operations, and Engineering on CAPA execution and remediation → Ensure compliance with global CAPA procedures: documentation standards, timeliness, and record retention → Assist with training and user guidance on CAPA procedures and EtQ workflowsMUST HAVE3–5 years of Quality Engineering experience, preferably supporting CAPA processesWorking knowledge of CAPA, root cause analysis, and quality system requirementsFDA 21 CFR Part 820 / QSR compliance knowledgeISO 13485 — Quality Management SystemsExperience with an electronic QMS (eQMS) platform — EtQ strongly preferredStrong technical writing and documentation review skillsGap assessment and compliance auditing abilityProficiency in Microsoft Office (Excel, Word, PowerPoint)B.S. in Engineering or equivalent Bachelor's degreeNICE TO HAVEISO 14971 — risk management principlesKnowledge of design controls, FMEA, and statistical analysisMedical device industry experience — orthopedic sector preferredCertified Quality Engineer (CQE) credentialExperience with document control systemsCross-functional stakeholder communication experienceEDUCATIONRequiredB.S. in Engineering or an alternative Bachelor's degree program3–5 years of experience in a Quality Engineering role, preferably supporting CAPAPreferredKnowledge of FDA QSR (21 CFR 820), ISO 13485, and ISO 14971Design controls, risk management, FMEA, root cause investigation, statistical analysisCertified Quality Engineer (CQE) certificationMedical device experience, particularly in the orthopedic industry