Supplier Quality Engineer (Entry Level)

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Job ID Number: 2014010859 Location: USA - CO - Boulder Job Description **Relocation assistance isnot provided SUMMARY OF POSITION: The Supplier Quality Engineer (SQE) is responsible for working with and developing finished goods suppliers on Quality Management System (QMS) related matters pertaining to qualification, manufacturing, QMS development, and technical quality/service/costs improvements for outside vended products and suppliers in the Americas. The SQE is a member of a global Contract Manufacturing team based in the USA and reports directly to the Quality Manager – Contract Manufacturing - Boulder. ESSENTIAL FUNCTIONS: Organize, direct and report on all supplier quality-related activities for contracted designed and manufactured items made in the Americas. Conduct audits at existing and new suppliers, develop correction action plans, and follow up with suppliers to ensure deficiencies/risks are mitigated. Develop, implement, and monitor supplier development initiatives, including supplier performance management, supplier certification, process improvements, cost reduction, supplier forums, Six Sigma/Lean integration, audits, and selectionactivities, that align with the Medical Supplies strategic goals and objectives. Ensure supplier compliancewith Covidien Quality Systems and all relevant internal procedures and policies. Investigate customer complaints that ensures adequate investigation and corrective actions are taken by suppliers. Manage Supplier Corrective Action Request program for assigned suppliers to ensure consistency in handling corrective actions by suppliers Work with new and existing suppliers to develop, implement, and maintain technical quality assurance systems and activities, to include Statistical Process Control, Quality Plans, Control Plans, and Failure Modes Effects Analysis. Support and communicate a strategy/plan for addressing finished goods supplier capability deficiencies, etc. Translate engineering, manufacturing, and quality requirements for outside supplied products. Perform deviation investigations into quality issues arising from supplier activities. Manage qualifications of changes, co-ordinates associated change control activities and supplier change requests (SCR) within the Agile product document control system. Conducts quick and efficient assessments of potential supplier’s Quality systems, with limited information. Work with the New Product Development Supplier Quality team on new projects with new suppliers and their associated quality and development plans. Promote a culture of continuous improvement and cost reduction with existing and new suppliers. Participate in annual supplier forums. OTHER FUNCTIONS: Participates in project teams associated with product, process or sourcing activities and improvements for outside vended products Responsible for supplier quality activities associated to sub-tier suppliers in the event of acquisitions and divestitures of outside suppliers. Evaluates purchased product performance as necessary and recommends and implements applicable improvements. Ensures statistical process tools are used effectively to reduce waste and product variability. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Other duties as assigned with or without accommodation. Maintains the professional competency, knowledge and skill necessary for the successful performance of assigned duties and responsibilities. Demonstrates company advocacy in interaction with both internal and external suppliers. REQUIREMENTS: EDUCATION: Bachelor’s Degree in a scientific or technical field required. REQUIRED SKILLS/EXPERIENCE: Entry level to Two years’ experience in a Supplier Quality, Quality Engineering or Reliability Engineering function. Preference is (1) year in the Drug/Medical Device industry.Effective in influencing and negotiating skills. Preferred previous internship with medical or technical companies that produce complex products or devices. Basic knowledge of quality tools and concepts. Demonstrated ability to work successfully in complex and emerging markets, leveraging interpersonal, communication, and technical skills to optimize results. Good problem solving skills. Excellent oral/written communication skills in Asia and US. Good analytical and statistical problem solving tools. Knowledge of software programs - Microsoft Word, PowerPoint, Excel, Project, Minitab, Agile. Multilingual is preferred, English is required PREFFERED EXPERENCE: Basic knowledge of test techniques, quality, statistical analysis. Preferred knowledge and experience in: supply chain management and supplier development, risk/issue management, implementation planning, training/communication, scope management. ORGANIZATIONAL RELATIONSHIPS/SCOPE: Works directly with Quality Manager – Contract Manufacturing Americas in developing existing and new finished goods suppliers. Works with other Supplier Quality Engineers to develop best practices for developing suppliers. Works with Marketing, R&D, Operational Excellence, and Program Management on supplier matters that affect product quality and availability. WORKING CONDITIONS: Usual office environment with frequent sitting, walking, and standing, and occasional climbing, stooping, kneeling, crouching, crawling and balancing. Frequent use of eye, hand, and finger coordination enabling the use of office machinery. Verbal and auditory capacity enabling interpersonal communication as well as communication through automated devices such as the telephone. Visual capacity including depth perception, color vision, and peripheral vision enabling operation of office machinery. Light physical effort required by handling objects Ability to travel frequently, both domestically and internationally (25-50%) Base Location is Boulder, CO DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. - See more at:
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