Quality Control Engineer

Job Description:Opportunity for a Quality-Focused Engineer in Medical ManufacturingOur client is currently hiring a Quality Assurance Engineer to join their growing operations in the medical device sector. This full-time role is perfect for a mid-level professional with 3 to 5 years of relevant experience who enjoys collaborating across teams and ensuring excellence in product quality, compliance, and manufacturing support.This position plays a key role in maintaining high standards across the production and product development life cycle ensuring all activities meet applicable regulatory and internal quality standards.What Youll Take Ownership Of:Drive material review activities and help lead weekly meetings focused on nonconformance evaluation and resolutionFollow up on vendor quality issues and coordinate disposition effortsMaintain calibration tracking systems to support precision in equipment usageWork closely with manufacturing engineers to develop and update documentation such as build records, process flows, BOMs, and manufacturing instructionsAssist with transitioning new products from R&D into production environmentsPerform component-level reviews for incoming materials to verify conformanceWrite and update standard operating procedures, inspection criteria, and lab test methodsEnsure all documentation and activities align with applicable regulations and company policiesSupport quality investigations involving customer complaints, internal deviations, and CAPA executionParticipate in internal audits and supplier performance evaluationsApply structured problem-solving techniques to assess root causes and support corrective/preventive effortsUse data-driven analysis to recommend and implement risk-based quality decisionsWho Were Looking For:3-6 years of hands-on quality experience in a regulated medical manufacturing environmentSolid understanding of FDA 21 CFR Part 820 and ISO 13485 standardsPrior experience executing and managing CAPAsKnowledge of validation protocols, including equipment, process, and test method validations (including Gage R&R)Experience with FEMA's and Risk ManagementComfortable using Microsoft Office Suite; proficiency in Excel is especially importantWorking familiarity with statistical analysis tools and methods; Minitab experience is a plusExcellent technical writing skills for protocol development and formal reportingThis Role Is a Fit If You:Thrive in a collaborative team environmentCan manage multiple priorities with attention to detailEnjoy troubleshooting and using data to guide decisionsAre driven to maintain the highest standards in product quality and complianceIf you're seeking a role where your input matters, your expertise is valued, and your impact is visible across the organization, we encourage you to apply.Required Skills:•Organization •Deviations •Protocol •Compliance •Operations •Analysis •Product Quality •Calibration •Assurance •ROOT •Attention To Detail •Ownership •Hiring •Excel •Validation •Product Development •Instructions •Reviews •Inspection •Quality Control •Quality Assurance •Manufacturing •Writing •Regulations •Records •Troubleshooting •Materials •Documentation •Microsoft Office