Supplier Qual Engineer Ii

Careers that Change LivesA Day in the LifeThe SupplierQuality Engineeris responsible for managing finished goods at Contract Manufacturer (CM) for Robotic Surgical Technologies.  Primary duties are focused on part qualification (PPAP), process improvements, supplier change requests, and all QMS-related matters pertaining to selection, qualification, manufacturing, QMS development, and technical quality/service/cost improvements. ESSENTIAL FUNCTIONS:Represent the supplier quality engineering function to develop and execute the strategy to organize, direct, and report on all CM quality-related activities for contracted design and manufactured items made for the businessLead PPAP qualifications with the CMsCollaborate with CMs to develop robust SCAPAsSupport the Quality team (member of) to develop and improve an effective Supplier Quality process that supports finished goods product quality globally.Work with new and existingCMs/Suppliers to develop, implement, and maintain technical quality assurance systems and activities, including MSAs, SPC, Quality Plans, Control Plans, and FMEAsCollaborate on New Product Development (NPD) teams to evaluate and understand future CMs and their associated quality and development plansBuild and own the strategy for managing the CMs/Suppliers for the businessCommunicate with the business Quality lead on CM initiatives, updates, and issuesPartner with Supplier Quality Managers to build a strategy for managing the CMs in all regionsEnsure CM compliance with business Quality Systems and all relevant internal procedures and policiesFacilitate customer complaints for CM products and ensure adequate investigation and corrective actions are taken by CMsManage Supplier Corrective Action Request program to ensure consistency in handling corrective actions by CMsDevelop, communicate, and manage a strategy/plan for addressing finished goods CMs/Suppliers capability deficiencies, etc.Ensure proper approval and documentation practices are followed for any process, material or tooling change (SCR – Supplier Change Request) at CMsDefine and manage the process for growing effective "partnerships" with preferred CMs (to drive optimal performance) founded on common interest and which demonstrate trust, loyalty and financial successMaintain compliance to set Key Performance Indicators for the businessMaintain the highest level of compliance and operational standards set by the businessManage and report on CMs/Suppliers audit program in line with ISO and/or FDA 21 CFR part 820 regulationsTranslate engineering, manufacturing, and quality requirements for CM productsPerform deviation investigations into quality issues arising from CM activitiesManage qualifications of changes and co-ordinates associated change control activitiesEvaluate CMs using the appropriate CM performance management processes and develop reports on CM quality performance for company management, recommend and implement the continuous improvement of CM quality systemsResponsible for ensuring that effective up-to-date CM Quality Assurance documentation, procedures, and specifications are maintainedOTHER FUNCTIONS:Participates in project teams associated with product, process or sourcing activities and improvements for contract-manufactured productsIs the liaison between business and CM sites for the deployment and communication of needs and new or improved quality requirementsResponsible for CM quality activities associated to sub-tier suppliers in the event of acquisitions and divestitures of CMsEvaluate purchased product performance as necessary and recommend and implements applicable improvementsParticipates on and assists teams and sourcing in making key CM product decisions that affect product performanceOccasionally acts as a technical resource to other businesses, departments, CMs, and customers to address and resolve issues with purchased productEnsures statistical process tools are used effectively to reduce waste and product variabilityWorks with internal auditors on audits or inspections required to be completed on the purchased productDEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:Other duties as assigned with or without accommodationMaintains the professional competency, knowledge and skill necessary for the successful performance of assigned duties and responsibilitiesDemonstrates company advocacy in interaction with CMsExperience:Minimum 3-5 years experience in a Supplier Quality, Quality Engineering Engineering function.  Demonstrated track record of effectively influencing and negotiating with all levels of an organization and leading effective/successful change initiatives Demonstrated knowledge and expertise in: supply chain management and supplier development, stakeholder management, risk/issue management, implementation planning, training/communication, scope managementKnowledge of plant operations preferredDesign Control knowledge preferredKnowledge of sterilization methods preferredThorough understanding of the US and international regulatory and quality assurance requirements associated with the development and manufacture of medical devices or drug productsElectronics Qualification/Experience would be an advantageWorking knowledge of inspection and test techniques, quality assurance procedures, statistical analysis, product usage and device regulationsKnowledge of Quality System Regulations (QSR) and ISO requirementAbility to budget for future expenditures and manage departmental budgetAbility to prepare and execute effective presentations to othersISO 13485:2003 Certified Lead Auditor6 Sigma and/or Lean experience preferred (trained or certified)Must Have: Minimum RequirementsBachelors degree requiredMinimum of 2 years of relevant experience, or advanced degree with 0 years of experienceNice to HaveExpert in PPAP process and requirementsExpert knowledge in corrective and preventive action (CAPA/SCAPA)High-level Supplier Change request knowledgeMastery of medical device quality systems and applications is requiredDemonstrated ability to work successfully in complex and emerging markets, leveraging interpersonal, communication, and technical skills to optimize resultsSelf-starter, with the ability to work independently and with all levels of managers, associates, and clientsCan effectively lead Change Management effortsExcellent oral/written communication skillsStrong analytical and statistical problem-solving toolsMastery of software programs - Microsoft Word, PowerPoint, Excel, Project, MinitabMultilingual is a plus, English is a requirementORGANIZATIONAL RELATIONSHIPS/SCOPE:Works directly with Quality Management in development of a finished goods CM quality programWorks with business Quality leads on communications and CM quality supportWorks with Quality Managers – Contract Manufacturing (peers) to develop metrics, best practices, and common processesWorks with Marketing on CM matters that affect product quality and availabilityWorks with R&D or related Engineering team on CM quality for new product developmentA commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.? We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here. This position is eligible for a short-term incentive plan.? Learn more about Medtronic Incentive Plan (MIP) on page 6 here.The provided base salary range is used nationally (except in certain CA locations).?The rate offered is compliant with federal/local regulations and may vary by experience,?certification/education, market conditions, location, etc.About MedtronicTogether, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.Physical Job RequirementsThe physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)