Save Job Back to Search Job Description Summary Similar JobsOpportunity to have an impact on people's lives3 weeks PTO, 4% annual bonusAbout Our ClientOur client is a medical device manufacturer specializing in electro-mechanical manufacturing processes. They are a growing organization as they are launching a brand new product line in which you will heavily support in your day-to-day responsibilities. They are ISO 13485 certified and their products and services are found in almost 50 countries. They offer an opportunity to make a meaningful impact on people's lives.Job DescriptionInvestigate and manage product complaints involving capital equipment, disposable products, serviced devices, field reports, and customer-reported issues while ensuring compliance with quality and regulatory requirements.Partner with Customer Support, Engineering, Manufacturing, Quality, and other cross-functional teams to assess complaints, determine investigation scope, prioritize risk, and involve suppliers when necessary.Escalate critical safety concerns, major quality issues, and investigation roadblocks to appropriate stakeholders in accordance with established procedures.Support regulatory reporting evaluations by maintaining thorough documentation and providing technical data needed for Quality and Regulatory decision-making.Maintain accurate, complete, and audit-ready complaint records, including investigation findings, root cause analysis, classifications, corrective actions, and customer communications.Ensure complaint investigations are closed in a timely manner and linked to risk management, CAPA, trend analysis, and continuous improvement initiatives.CAPA & Continuous ImprovementLead or support Corrective and Preventive Action (CAPA) activities resulting from complaint investigations and identified quality trends.Drive escalations for issues requiring improvements to products, processes, suppliers, servicing, labeling, design, or quality systems.Analyze complaint, CAPA, nonconformance, supplier, and post-market data to identify opportunities for quality and operational improvements.Review Boards & Performance MetricsEvaluate complaint, service, repair, and failure data to identify recurring issues, emerging risks, and adverse quality trends.Develop and report KPI metrics for Complaint Review Boards, CAPA Reviews, Management Reviews, Quality System Reviews, and audit support activities.Coordinate and lead Complaint Review Board meetings, including preparation of presentations, trend analyses, action items, and escalation summaries.Support CAPA Review Board activities by tracking progress, effectiveness, priorities, aging actions, and cross-functional follow-up requirements.MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.The Successful ApplicantBachelor's Degree (Engineering-related preferred)4+ years of manufacturing experience within qualityUnderstanding of ISO 9001Experience with electro-mechanical processesMedical device experience is preferredCombination device experience is preferredExperience working with capital equipmentExperience working with sterile products is preferredUnderstanding of ISO 14971 and UL 60601 is preferredCQE certification is preferredSix Sigma belt is preferredSponsorship is not providedWhat's on OfferBase salary between $100k-$115kHealth, dental, vision401(k) matching3 weeks PTO4% annual bonus incentiveContactTrevor WojcikQuote job refJN-092026-7100574Job summarySectorEngineering & ManufacturingSub SectorProduction, ManufacturingIndustryIndustrial / ManufacturingWhereElk Grove VillageContract TypePermanentConsultant nameTrevor WojcikJob ReferenceJN-092026-7100574
