Job Title: Supplier Quality Engineer II Job Description The Supplier Quality Engineer II is responsible for all aspects of supplier quality including but not limited to the supplier quality process, supplier non-conformances, supplier change process/notifications, supplier audit, qualification and approval including supplier quality agreements. Responsibilities + Manage supplier performance and raise potential issues to supplier quality management. + Support supplier risk assessments and update the Approved Supplier List. + Act as lead auditor for supplier quality audits according to the established supplier audit schedule. + Communicate with suppliers for change notifications and timely follow-up actions both internally and externally. + Support the dispositioning of nonconforming material from suppliers in a timely manner and analyze defect trends to initiate appropriate supplier corrective actions. + Assist suppliers with conducting FMEA, process capability studies, and DOE. + Perform Quality Systems and Process Audits of current and prospective suppliers, including reporting, follow-up, and closure of nonconformances. + Recommend opportunities for cost reduction and quality improvements with suppliers. + Support Supplier Quality Engineer III to develop and implement improvements to supplier quality policies, processes, and procedures. + Collaborate cross-functionally to ensure accurate component specifications are created and implemented as needed. + Coordinate the approval of new suppliers and communicate status to pending suppliers. + Support developing and implementing methods and procedures for inspecting, testing, and evaluating the precision, reliability, and accuracy of supplier products and processes. + Coordinate with customers and suppliers relating to quality performance, trends, and corrective actions. + Work with suppliers to continuously improve products and processes through lean manufacturing and six-sigma principles and techniques to assure the quality of goods and services provided. + Support the APQP process in design and process reviews. + Manage qualification of supplier process change requests inclusive of defining customer requirements as necessary. + Assess supplier process capability for new components, processes, assemblies, and/or purchased finished goods. Essential Skills + Supplier quality management and vendor management experience. + Auditing experience. + Medical device industry experience. + 4+ years of experience in quality assurance. Additional Skills & Qualifications + Bachelor’s degree in Engineering or a related field is required. + 4-7+ years of quality experience in a manufacturing environment or equivalent combination of education and experience is required. + Experience reading and interpreting blueprints and gage design knowledge is required. + Experience with Lean and Six Sigma methodologies preferred. + Direct experience leading supplier quality investigations and CAPA activities is required. + Professional auditing certification by ISO, ASQ, or similar preferred. + In-depth knowledge of 21 CFR 820 and ISO is required. Work Environment This role requires working 5 days a week in a manufacturing environment. The company provides an excellent benefits package, compensation higher than the industry average, and a full complement of training programs dedicated to giving employees the skills and knowledge required to achieve their career goals. Pay and Benefits The pay range for this position is $48.07 - $55.28/hr. 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. If eligible, the benefits available for this temporary role may include the following: • 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 Somerset,NJ. Application Deadline This position is anticipated to close on Feb 13, 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.