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Job DetailsJob Location: Donatelle - New Brighton - New Brighton, MN 55112Position Type: Full TimeSalary Range: $67,000.00 - $80,000.00 Salary/yearJob Shift: 1st ShiftQuality Engineering Responsibilities Lead Material Review Board (MRB) process Lead Continual Improvement (CI) projects for process and part specific improvements Lead customer complaint investigation and corrective action activities Responsible for implementing and monitoring of Statistical Process Control (SPC) on production jobs Develop manufacturing process and software validation protocols and reports Lead efforts to meet Quality Objectives established through business planning Work with cross functional groups to generate a written response to customer’s request for corrective action Use DMAIC Roadmap to lead process improvements Lead Internal Quality System audits Update part specific Quality Work Instructions and Inspection Plans per engineering change order requirements Support Quality Inspectors and Technicians on inspection and test methods and equipment concerns Supplier Development Responsibilities Primary 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 Agreements Price & cost drivers Supplier relationship management Handle 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 Responsibilities Responsibility to protect confidential information and intellectual property Perform other duties as assigned Follow safety requirements as defined in the Safety Manual Provide back-up support for the Senior Quality Manager Benefits and Pay: Benefits: Medical insurance Dental insurance Basic and voluntary life insurance Short and long-term disability insurance 401(k) retirement options with a company match Paid time off Paid holidays Annual incentive bonus opportunities Flexible spending accounts Educational assistance and tuition reimbursement programs Pay: Salary range: $67,000 to $105,000 QualificationsPreferred Qualifications: Education/Experience: Bachelors degree in engineering or technical degree and 8+ years of relevant experience 3+ years Quality Engineering experience in a medical or other high-tech manufacturing environment Other Qualifications and Desired Skills: Solid communication and human relations skills Strong problem solving and troubleshooting abilities Comprehensive knowledge of Statistical Process Control Comprehensive knowledge of blue print reading and geometric dimensioning and tolerance Ability to use inspection equipment, such as micrometers, tool scopes, coordinate measuring machines CMM’s Basic knowledge of cGMPs, ISO 9001 and ISO 13485 ASQ QE certification and Green Belt training desired Experience using quality tools including FMEA, DOE, and capability analysis Knowledge of injection molding processes and equipment, scientific molding methodology, process monitoring systems, and precision machining Knowledge of manufacturing operations such as welding, pad printing, assembly, and bonding Knowledge of thermoplastic, liquid silicone, titanium, stainless steel, and other materials
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