Quality Engineer

Company OverviewRöchling Medical Rochester is a leader in the medical device manufacturing sector, part of The Röchling Group. With a strong focus on contract manufacturing, product design, and mold making, we deliver high-quality surgical, laboratory, and diagnostic devices through precise engineering and robust program management.

Learn more about the general tasks related to this opportunity below, as well as required skills.
Job Summary:The Quality Engineer is responsible for leading quality engineering activities that ensure products, manufacturing processes, and quality systems meet all applicable regulatory, customer, and company requirements. This role provides technical leadership for quality initiatives, supports new product development and validation, drives continuous improvement efforts, and partners cross-functionally to improve product quality and manufacturing performance.
Essential Duties/Responsibilities:Support Engineering Development and Validation activities.IQ, OQ, PQ SubmissionsDocument IQ, OQ, PQ ProtocolsDocument IQ, OQ, PQ SubmissionsSoftware validationAutomated program validationMeasurement System Analysis (MSA) / Gage R&R / Measurement System ValidationCleanroom validationPerform Data Analysis using MinitabCapability AnalysisANOVA StudiesDevelop Qualification DocumentationDevelop Control PlansDevelop PFMEA and risk documentationDevelop Process Flow Investigate Product and Process Nonconformities, Complaints, and CAPAs using Problem Solving & Root-cause Analysis Tools:5-why AnalysisFishbone AnalysisScheduling Brainstorm sessionsDocumenting Continuous Improvement ActivitiesTracing production history throughout ERP, and other systemsSupport AuditsInternal AuditorSubject Matter Expert during external auditsBackroom support during auditsPerform supplier auditsLead process auditsMonitor and analyze quality performance and present metricsDevelop and optimize inspection strategies and methodsDevelop sampling plansSelect appropriate inspection methods & equipmentGage design and developmentData collection strategiesDrive Quality and Improvement projectsComplete change ordersReview and submit supplier change requests/ notificationsWrite and revise Forms, Work Instructions and SOP’s Train others on process changesWork with suppliers to enhance the supply chainCommunicate and manage MRR – Material Rejection Reports to suppliersDrive supplier improvement using the SCAR processEvaluate and qualify new suppliersCommunicate directly with customers throughoutProject meetingsQuality issues
Required Skills/Abilities: Excellent verbal and written communication skills. Excellent interpersonal and customer service skills.Excellent organizational skills and attention to detail.Strong understanding of FDA (21 CFR Part 820/QMSR), and ISO 13485 Quality SystemStrong analytical and problem-solving skills.Strong leadership skills.Ability to prioritize tasks and to delegate them when appropriate.Ability to function well in a high-paced and at times stressful environment.Ability to simplify complex situations and present them with an appropriate level of detailAbility to analyze risk and make decisionsProficient with statistical softwareProficient print reading skills including GD&TAbility to travel as required to Suppliers, Customers, and other events. Up to 10%

Education and Experience:BS degree in Engineering, Quality, Manufacturing, or related technical discipline.5 years of Quality Engineering experience in a regulated manufacturing environment.
PreferredMedical device manufacturing experience.Experience with injection molding and process validation.Experience supporting ISO13485 audits.ASQ Certified Quality Engineer (CQE).Lean Six Sigma Green Belt or Black Belt certification.
Physical Requirements: Prolonged periods of sitting at a desk and working on a computer.Must be able to lift up to 15 pounds at times.Visual acuity for inspections, color differentiation, reading electronic documentation.
Work Environment:Manufacturing environment requiring appropriate eye protection.Exposure to high noise level in the work environment requiring hearing protection.Gowning and sanitation for manufacturing in a clean room, as applicable.
Roechling Medical Rochester is an Equal Opportunity Employer. RMR does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. xzbcwsv
Job Type: Full-timePay: $75,000.00 - $95,000.00 per yearBenefits:401(k)401(k) matchingDental InsuranceHealth insuranceHealth savings accountLife insurancePaid time offTuition reimbursementVision insurance
Compensation Package:Bonus opportunitiesSchedule:8 hour shiftDay shiftAbility to Commute:Rochester, NY 14615 (Preferred)
If you are ready to make a significant impact in the medical device industry with your engineering expertise, we invite you to apply today to join our innovative team at Röchling Medical!