Quality Engineer I

Quality Engineer IDonatelle - New Brighton - New Brighton, MN 55112OverviewSalary Range $67,000.00 - $80,000.00 Salary/year Position Type Full Time Job Shift 1st ShiftDescriptionQuality Engineering ResponsibilitiesLead Material Review Board (MRB) processLead Continual Improvement (CI) projects for process and part specific improvementsLead customer complaint investigation and corrective action activitiesResponsible for implementing and monitoring of Statistical Process Control (SPC) on production jobsDevelop manufacturing process and software validation protocols and reportsLead efforts to meet Quality Objectives established through business planningWork with cross functional groups to generate a written response to customer's request for corrective actionUse DMAIC Roadmap to lead process improvementsLead Internal Quality System auditsUpdate part specific Quality Work Instructions and Inspection Plans per engineering change order requirementsSupport Quality Inspectors and Technicians on inspection and test methods and equipment concernsSupplier Development ResponsibilitiesPrimary role is to ensure that the technical requirements for purchased items or services are clearly identified, communicated, and managed.Work in conjunction with the Sr Buyers/Estimating/Engineering groups to identify sourcing options – considering ASL, pricing, timing, technical capabilities, supplier quality systems, etc.Guide the Design for Supplier (DFS) process to ensure that appropriate specifications are developed and managed (Prints, ISR, Outsource Specifications, Material Specifications, etc.)Ensure that incoming receiving plans are established and monitored to ensure reasonable confidence that supplied materials/services meet established specifications.Work closely with suppliers to ensure clear understanding of specifications and requirements.Monitor performance of supplied material/services at all stages of the product lifecycle – incoming receiving, development process and PQ runs, ongoing manufacturing.Create and implement key supplier development processes, and strategies designed to achieve expected supplier performance, development and improvement.Develop a strategy and scope for various types of supplier audits. Conduct supplier audits to ensure that supply base aligns with business needs. Review and approve quality system audit reports.Work with Buyers in support of developing and maintaining strategic supplier partnerships that will provide competitive advantages in lowest total cost, highest quality, and superior customer service.Develop alternative suppliers for each key material/service based on current supplier performance, risk and business needs.Manage supplier quality through corrective actions.Lead resolution of supplier-related technical and quality issues.Work closely with the Sr. Buyers to initiate the commercial aspects of our supplier relationships when establishing new sources of supply.Supply AgreementsPrice & cost driversSupplier relationship managementHandle customer inquiries for material purity directives (i.e. RoHS, REACH, Tallow Derivates, etc.) by contacting suppliers for information.Work in conjunction with the manufacturing engineering group and Business Continuity Managers to explore and implement sourcing changes – cost savings, performance related.Handle technical related Supplier Change Notifications (Material/Process Changes)Assess suppliers & potential suppliers for their position as a competitor implementing and following appropriate guidelines & safeguards to appropriately protect confidential information.General ResponsibilitiesResponsibility to protect confidential information and intellectual propertyPerform other duties as assignedFollow safety requirements as defined in the Safety ManualProvide back-up support for the Senior Quality ManagerBenefits and Pay:Benefits:Medical insuranceDental insuranceBasic and voluntary life insuranceShort and long-term disability insurance401(k) retirement options with a company matchPaid time offPaid holidaysAnnual incentive bonus opportunitiesFlexible spending accountsEducational assistance and tuition reimbursement programsPay:Salary range: $67,000 to $105,000QualificationsPreferred Qualifications:Education/Experience:Bachelors degree in engineering or technical degree and 8+ years of relevant experience3+ years Quality Engineering experience in a medical or other high-tech manufacturing environmentOther Qualifications and Desired Skills:Solid communication and human relations skillsStrong problem solving and troubleshooting abilitiesComprehensive knowledge of Statistical Process ControlComprehensive knowledge of blue print reading and geometric dimensioning and toleranceAbility to use inspection equipment, such as micrometers, tool scopes, coordinate measuring machines CMM'sBasic knowledge of cGMPs, ISO 9001 and ISO 13485ASQ QE certification and Green Belt training desiredExperience using quality tools including FMEA, DOE, and capability analysisKnowledge of injection molding processes and equipment, scientific molding methodology, process monitoring systems, and precision machiningKnowledge of manufacturing operations such as welding, pad printing, assembly, and bondingKnowledge of thermoplastic, liquid silicone, titanium, stainless steel, and other materials