Senior Engineer, Quality Assurance Engineering

6 days ago

Redmond, United States The Judge Group Full time

Our client is currently seeking a Senior Engineer, Quality Assurance Engineering for an 18 month
contract.This is NOT an IT role.Medical device experience is preferred.
Top 3 skills: Multi-tasking, strong communication, problem solvingOverview of the project and day-to-day activities:This would be a universal player conducting Quality Engineering based work. Their day to day will likely vary, depending on what is going on in the manufacturing space and business needs. They will own NCs and potentially CAPAs, needing to bring in cross functional teams, driving with urgency to resolve the issue. They will contain nonconforming product and work with the Operations team when a line down situation occurs, which is a fast-paced environment. They will also work with Operations to ensure quality performances of products and processes. They will own PPAPs, for supplier changes, which can be an urgent change or ones that are less urgent. They may also be brought into process improvements/validation reviews for internal efforts.Key Areas of Responsibility:• Work closely with Operations and the business functions to ensure quality performance of product and processes.• Non-Conformanceso Collaborate with Internal cross-functional and Supplier teams to address top quality issues.o Own identified internal and supplier-driven Non-Conformances (NC) and Corrective Action Preventative Action records (CAPA), managing the timely processing and closure of NC and CAPA records within the electronic management system, Trackwise.o Support execution and analysis of manufacturing related complaint investigations and product field actions.o Investigate and disposition internal non-conforming product within MRB, issuing NCs as appropriate.• Supplier Activitieso Communicate & collaborate with suppliers regarding non-conformances, escalating Supplier Corrective Action Requests (SCAR) as required.o Execute and manage Supplier Initiated Change Requests (SICRs) received from suppliers, engaging with cross-function teams for assessment and approvalo Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.o Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification.• Process Improvements/Validationo Engage in the development and improvement of the internal manufacturing and distribution processes for existing products.o Perform critical assessments and qualifications of internal and supplier-proposed change management activities, including Production Part Approval Process (PPAP) activities for supplier changes.o Participate in and potentially lead the creation and/or review of new or modified procedures.o Support the development and review of process and equipment validation/qualification and MSA of internal processes.o Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.• Perform other related duties as assigned.Education - BA Degree in Science/Technical field or related field **Minimum of 3 years of experience **Top Operations/Manufacturing Experience **CAPA Experience **Top 3 Skills (Multi-tasking, Strong communication and Problem Solving) **Systems - TrackWise/ERP Systems experience, MS Suite Experience **Power BI knowledge a PLUS but not required • Strong quality background with CQE and/or LSSGB or LSSBB certification • Previous medical device industry experience desired with understanding of US and International Medical Device Regulations, familiarity with ISO 13485, GDP, GMP as well as experience interacting with regulatory agencies (FDA, MoH, TUV, etc.) and in working in compliance risk situations. • Strong knowledge of and experience with key Quality concepts (e.g. Risk Management, CAPA, Audits, Statistics, DMAIC, DFSS). • Strong project management, leadership, and influencing skills as well as ability to manage multiple tasks simultaneously. Demonstrated ability to successfully manage and complete projects in a matrix organization as well as to work independently and as part of cross-functional teams. • Ability to represent Quality function within project teams. • Strong interpersonal skills, written communication, oral communication, and negotiations skills.• Highly-developed critical, problem solving, analytical, and \"outside the box\" thinking. • Ability to work in a fast-paced, dynamic, and time-critical manufacturing environment • Strong computer literacy (Excel, Databases, ERP Systems, Trackwise, Statistical software packages, etc).

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