Job Title: Senior Engineer, Quality Assurance Engineering - Individual Contributor Job Description We are seeking a highly skilled Senior Engineer in Quality Assurance Engineering to join our team as an individual contributor. You will collaborate closely with Operations and business functions to ensure the quality performance of products and processes. The ideal candidate will have a strong background in quality assurance within manufacturing environments, with a focus on non-conformances, supplier activities, process improvements, and validations. Responsibilities + Work closely with Operations and business functions to ensure quality performance of products and processes. + Collaborate with internal cross-functional and supplier teams to address top quality issues. + 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. + Support execution and analysis of manufacturing-related complaint investigations and product field actions. + Investigate and disposition internal non-conforming products within MRB, issuing NCs as appropriate. + Communicate and collaborate with suppliers regarding non-conformances, escalating Supplier Corrective Action Requests (SCAR) as required. + Execute and manage Supplier Initiated Change Requests (SICRs) received from suppliers, engaging with cross-functional teams for assessment and approval. + Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities. + Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification. + Engage in the development and improvement of internal manufacturing and distribution processes for existing products. + Perform critical assessments and qualifications of internal and supplier-proposed change management activities, including Production Part Approval Process (PPAP) activities for supplier changes. + Participate in and potentially lead the creation and/or review of new or modified procedures. + Support the development and review of process and equipment validation/qualification and MSA of internal processes. + 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. Essential Skills + Bachelor's Degree in Science/Technical field or related field. + Minimum of 3 years of experience in a quality assurance role. + Experience with CAPA processes. + Strong operations/manufacturing experience. + Proficiency with TrackWise and ERP systems. + Experience with MS Suite. + Strong multi-tasking, communication, and problem-solving skills. Additional Skills & Qualifications + Power BI knowledge is a plus. + Quality background with CQE and/or LSSGB or other certifications. + Previous medical device industry experience is desired, with an understanding of US and International Medical Device Regulations. + Familiarity with GMP, GDP, and experience interacting with regulatory agencies (FDA, MoH, TUV, etc.). + Knowledge of and experience with key quality concepts (e.g., Risk Management, CAPA, Audits, Statistics, DMAIC). + Strong project management, leadership, and influencing skills. + Ability to manage multiple tasks simultaneously and to work independently or as part of cross-functional teams. + Excellent interpersonal, written communication, oral communication, and negotiation skills. + Highly-developed critical, problem-solving, analytical, and creative thinking skills. + Ability to work in a fast-paced, dynamic, and time-critical manufacturing environment. + Proficiency in computer literacy, including Excel, databases, ERP systems, TrackWise, and statistical software packages. Work Environment The work environment is dynamic and fast-paced, requiring the ability to manage multiple tasks simultaneously. You will work with advanced technologies and equipment, including ERP systems, TrackWise, and statistical software packages. The role involves cross-functional team collaboration, often in a matrix organization. Dress code is business casual. We reserve the right to pay above or below the posted wage based on factors unrelated to sex, race, or any other protected classification. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. This temporary role may be eligible for the following: · Medical, dental & vision · 401(k)/Roth · Insurance (Basic/Supplemental Life & AD&D) · Short and long-term disability · Health & Dependent Care Spending Accounts (HSA & DCFSA) · Transportation benefits · Employee Assistance Program .Time Off/Leave (PTO, Vacation or Sick Leave) Pay and Benefits The pay range for this position is $35.50 - $43.50 • Medical, dental & vision• Critical Illness, Accident, and Hospital• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available• Life Insurance (Voluntary Life & AD&D for the employee and dependents)• Short and long-term disability• Health Spending Account (HSA)• Transportation benefits• Employee Assistance Program• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Redmond,WA. Application Deadline This position will be accepting applications until Jan 27, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.