Quality Engineer

Quality Assurance Engineer – Medical DeviceDirect HireAbout the OpportunityWe are looking for a Quality Assurance Engineer to become a core part of a contract manufacturing medical device organization. This is a permanent role for someone who wants to plant roots, build something, and grow with a team. You will provide operational quality input across manufacturing programs throughout the product lifecycle while supporting development activities as they transition into commercial manufacturing — including manufacturing readiness, audits, and clinical builds — ensuring a compliant and accurate Design History File from day one.What You'll OwnDocument Control & Audit Readiness — Author and approve SOPs, work instructions, and forms. Maintain inspection readiness and support internal and external audits across the quality systemData & Continuous Improvement — Compile and trend quality metrics to identify systemic issues. Present actionable insights to leadership and drive CAPA implementationIncoming Inspection & Supplier Quality — Oversee incoming inspection per approved sampling plans. Disposition nonconforming materials and coordinate supplier corrective actionsEquipment & Process Oversight — Provide quality oversight for IQ/OQ/PQ qualification activities. Review and approve protocols, reports, and change orders. Evaluate regulatory impact prior to implementationNC & CAPA Leadership — Manage nonconformances and CAPAs from initiation through effectiveness verification. Lead root cause analysis using structured methods (5-Why, fishbone) and report findings at management reviewDay-to-Day Operations SupportServe as the quality point of contact for productionReview batch records and travelers for GMP complianceSupport line clearances, first-article inspections, and process change reviewsDraft, collaborate on, and approve product and engineering work ordersCreate and maintain up-to-date Design History Files (DHF)Advise project teams on quality and regulatory best practicesReceive, investigate, and document product complaints, interacting with customers as applicableSupport audits as SME for QMS processes and product DHFsDrive PLM architecture and changes as neededWhat We're Looking ForBachelor's degree in a life science discipline or equivalent experience5+ years in medical device development, or 3+ years in a Design Assurance or Quality Engineering roleWorking knowledge of 21 CFR 820 and ISO 13485Background as a development project team member on complex medical device programs, including systems-level workUnderstanding of ISO 14971 and application of risk management to products and processesDemonstrated technical leadership in quality with strong attention to detailStrong written and verbal communication skills across disciplines and organizational levelsExperience with PLM software such as Windchill, Agile, or PropelIntermediate to advanced Microsoft Office proficiencyFamiliarity with Minitab or similar statistical software preferred#J-18808-Ljbffr