Quality Engineer

Quality Engineering LeaderThis position utilizes Quality Engineering and Quality Assurance techniques to support new product development (NPD), product line maintenance, quality initiatives for new acquisitions, and overall Risk Management Program upkeep. The role ensures compliance with all applicable federal, industry, and corporate procedures, guidelines, and regulations during the receipt, storage, manufacture, and distribution of products.Roles & Responsibilities:Provide Quality Engineering leadership for NPD, tech transfer, and acquisitionsLead resolution of quality issues across cross-functional teamsReview and approve validations for equipment, processes, and softwareCollect, analyze, and present statistical data to support validations and engineering studiesAssist in developing, implementing, and documenting qualifications/validationsPerform calibration activities as requiredPartner with Facilities to ensure proper preventive maintenanceCollaborate with manufacturing facilities as neededMaintain Risk Management Program policies and documentationIdentify hazards, risk probabilities, severities, and mitigations for Risk AnalysesEnsure periodic Risk Management File reviews occur on scheduleEvaluate labeling, process, and product changes for RMF impactMonitor post-market data (complaints, CAPAs, NCRs, customer feedback)Provide investigation reports, evaluations, and risk assessments to other departmentsMaintain knowledge of applicable standards, regulations, and proceduresSupport creation and review of Design History File documentsPerform internal and supplier audits as assignedAnalyze non-conformances and implement corrective and preventive actionsExecute high-visibility Risk Management projects as neededPartner with Sustaining Engineering to support new product development and commercial launchEnsure proper application of design controls, risk management, and investigation/correction of design issuesSupport translation of design input requirements into design outputsOwn sampling plan strategy across defect types, severity, patient risk, process capability, and classificationEstablish and/or maintain Risk Management Files for product lines and corporate projectsReview and approve verification/validation protocols and reportsConduct investigation, documentation, and approval of non-conformances, CAPAs, and complaints.Requirements:Bachelor's degree in Engineering or a science-related field (or equivalent work experience).5-10 years of hands-on experience, preferably in an FDA-regulated industry (pharmaceutical, biomedical, or medical device), with strong knowledge of GMPs, QSR, and ISO standards main focus will be to perform validations during this growth period over the next year.Need this person to be specialized in equipment/process (they have a few others covering software) must be strong in IQ/OQ and protocol/report writing.Strong understanding of statistical methods and acceptance sampling in regulated environments.Proficient with PC tools (Word, Excel, data analysis software).Risk Management experience preferred but not required.ASQ, CQE, or CQA certifications preferred but not required.Support implementation of corporate quality, project management, process development, and compliance procedures.Review and analyze validations for equipment, processes, and software.Communicate effectively with all levels of the organization.Manage and prioritize multiple projects in a fast-paced environment.Maintain RMFs and evaluate post-production data for impact.