Quality Engineer

Senior Quality Assurance Engineer Location: Redmond, Washington About Our Client: Accepting no less than the absolute best, our client has climbed to the top, gaining a reputation for both excellence and satisfaction. Working at this company will give you the opportunity to work with some of the top technical professionals in the industry who are bringing cutting-edge products to forefront. Offering results-driven people a place where they can truly make a difference on a daily basis, this is an opportunity you will not want to miss! Key Responsibilities:

Working closely with operations and the business functions to ensure quality performance of product and processes. Collaborating with internal cross-functional and supplier teams to address top quality issues. Owning 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. Supporting execution and analysis of manufacturing related complaint investigations and product field actions. Investigating and disposing internal non-conforming product within MRB, issuing NCs as appropriate. Communicating & collaborating with suppliers regarding non-conformances, escalating supplier corrective action requests (SCAR) as required. Executing and managing supplier-initiated change requests (SICRs) received from suppliers, engaging with cross-function teams for assessment and approval. Supporting manufacturing transfers to/from other plants/facilities, executing appropriate quality activities. Collaborating with appropriate stakeholders to identify and execute opportunities for supplier part certification. Engaging in the development and improvement of the internal manufacturing and distribution processes for existing products. Performing critical assessments and qualifications of internal and supplier-proposed change management activities, including production part approval process (PPAP) activities for supplier changes. Participating in and potentially leading the creation and/or review of new or modified procedures. Supporting the development and review of process and equipment validation/qualification and MSA of internal processes. Maintaining KPIs for monitoring of process and/or product quality, performing analysis, and interpreting trends, identifying and activating on appropriate actions as necessary.

Qualifications:

Bachelor's Degree in Science/Technical field or related field. Minimum of 3 years of related quality assurance experience. Top Operations/Manufacturing experience. CAPA experience. TrackWise/ERP Systems experience, MS Suite Experience. 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 computer literacy (Excel, Databases, ERP Systems, Trackwise, Statistical software packages, etc). Power BI knowledge a PLUS but not required. NO C2C CANDIDATES

Interested Candidates please apply on our website at https://jobs.jblresources.com {rel="nofollow"}. For more information about our services and great opportunities at JBL Resources, plea