The Judge Group, INC
Our client is currently seeking a Supplier Quality Auditor in Redmond, WA.11 month contractCore Roles and responsibilitiesLead the planning, leading, executing, and post-processing of supplier QMS and process audits.Identify and communicate issues that may impact product quality, system gaps or cause interruptions in business continuity.Prepare and complete audit reports and communicate with internal teams and suppliers within a timely manner per local procedural requirements.Ensure audit findings are properly contained and suppliers implement proper corrective actions that rectify identified gaps. Maintain supplier audit files and ensure all files are properly filed into the proper systems (i.e. Supplier Audit Management (SAM)Basic FunctionLead supplier evaluations in the Global Quality & Operations (GQ&O) audit program to support the evaluation, selection, approval, and monitoring of suppliers and manufacturing partners. The role is responsible for the coordination and implementation of on-site and documentation audits, related CAPA and communication of evaluation results to key stakeholders. Provide divisional and cross-functional supplier auditing services to R&D, Acquisition, Manufacturing, Materials, Purchasing, and Operations stakeholders worldwide. Work with cross-divisional and cross-functional component suppliers, contract manufactures, and original equipment manufacturers to drive process improvements of the quality systems. Sr. Audit Supplier Quality Engineers act as a technical liaison between suppliers, Engineering, Purchasing, and Manufacturing, to support projects and to resolve divisional and site quality issues. Sr. Audit Supplier Quality Engineers partner with more experience staff. They are viewed as divisional and cross-functional subject matter expert in Quality and auditing. Ensure purchased components, sub-assemblies, and devices comply with all print specifications and applicable regulations. Supply information into the metrics, trends, and performance indicators of suppliers in order to drive continuous improvement throughout the supply chain. Provide input into the supplier performance information and selection of new suppliers for the Global Approved Supplier List. The top three performance objectives for this role are: (1) drive continuous improvement within the supply base, (2) ensure compliance and conformance, and (3) ensure effective and efficient Quality Management Systems are established, documented, implemented, and maintained.Responsibilities related to compliance:Complete risk-based audits of suppliers per required cycle times to ensure conformance and compliance Lead timely and compliant Operations audits as required and directed by the internal audit programProvide compliant records for FDA, ISO, Corporate, Internal, 2nd party, and Operations auditsEnsure supplier Quality Management Systems comply with applicable FDA and ISO regulations and requirementsIdentify and write findings and observations during evaluations and drive timely closure of NCs through the CAPA systemEnsure components, sub-assemblies, and devices meet all print specifications and applicable regulationsWork with suppliers to quarantine all suspect and non-conforming material, as requiredIssue supplier corrective action requests, as required, and drive suppliers to identify, correct, and prevent the root causeParticipate in supplier audits, supplier evaluation, and supplier monitoring as requiredTrain and educate suppliers on GMP, regulatory requirements, and company expectationsResponsibilities related to sustainment:Evaluate processes, write audit reports, write non-conformances, and store records per Document Control requirementsEnsure a timely supply of conforming components and products to company through process sustainmentRoot cause analysis of processes related manufacturing defects and warranty concernsCommunicate results of supplier evaluations to stakeholders and suppliers to ensure adequate responsiveness Identify and communicate supplier initiated changes and ensure the suppliers follow change control requirementsServe as a subject matter expert for supplier evaluations, share expertise within the division and site Support manufacturing transfer projects through the effective and efficient evaluation of suppliers and processes Responsibilities related to development:Foster strong relationships with supplier-partners acting as an extended enterprise Complete on-site audits of suppliers’ Quality Management Systems through risk based processes auditsDrive improvement by identifying and communicating ineffective or inefficient Quality Management System processesReport non-conformance and performance data to highlight systemic supplier issuesSupport the creation and execution of supplier development plans by identifying potential process improvementsDrive continuous improvement actions within supplier processes to reduce part related defects (DMP)Evaluate and qualify new suppliers and advanced technology processes to support product innovationSupport strategic sourcing decisions by identifying supplier capabilities and providing input for supplier selectionPartner with suppliers on Quality topics: Quality System, problem solving, validation, and leanCommunicate “lessons learned” from the supply base to R&D for incorporation into next generation designsBecome recognized and trusted as a divisional and site auditor expert and resource Qualifications & Requirements:Bachelor of Science in engineering, or engineering related discipline requiredKnowledge of Quality Management Systems, FDA 21 CFR Part 820, ISO13485 and/or ISO9001 requiredASQ or RABQSA certification preferred (i.e. CQE, CQA, Lead Auditor)ISO-13485 Lead Auditor certification or equivalent preferred3 years of relevant experience in Quality, Management, or EngineeringExperience in medical device industry preferredExperience working onsite developing suppliers preferredExperience conducting supplier audits and internal audits preferredDemonstrated collaboration, negotiation, and conflict resolution skillsDemonstrated ability to lead, champion change, and execute strategies to meet goalsCritical thinking and strong analytical skillsComprehends production/process controls, FDA verification/validation, problem solving, & root cause Comprehends quality planning tools: APQP, PPAP/FAI, FMEA, MSA, Control Plan, & Control ChartsComprehends statistics and use of Minitab software: SPC, MSA, DOE, and Process Capability Strong communication skills, verbal and writtenExcellent time management and organization skills, with high emphasis on attention to detailAdvanced working knowledge of Microsoft Word, Excel, Outlook, PowerPoint, Visio, and Adobe *Travel is approximately 50% Regular travel to supplier facilities required. Must be able to travel internationally* \r
The Judge Group, INC
Website : http://www.judge.com/
Working at the crossroads of people and transformative technologies, The Judge Group delivers innovative business solutions - powered by top talent - to help organizations reach their strategic goals and realize opportunities now and in the future. The Judge Group is a leading professional services firm specializing in technology, talent, and learning solutions. Our services are successfully delivered through a network of more than 35 offices in the United States, Canada, China, and India. The Judge Group serves more than 40 Fortune 100 companies and is responsible for the placement of more than 5,000 professionals annually across a wide range of industries.