Job Title: Supplier Quality EngineerJob Description The Supplier Quality Engineer is responsible for ensuring the quality of products throughout the manufacturing process, from raw materials to finished goods. This includes inspecting and testing materials, equipment, processes, and products to ensure they meet quality specifications and regulatory requirements. The role involves identifying and resolving quality issues, implementing corrective actions, and driving continuous improvement in manufacturing processes. Responsibilities + Implement and maintain quality control plans and procedures to ensure products meet standards. + Identify areas for improvement in manufacturing processes and implement solutions to enhance quality and efficiency. + Investigate and resolve quality issues, including root cause analysis, corrective actions, and preventive measures. + Maintain accurate records of quality data, inspection results, and corrective actions. + Collaborate with other departments, such as engineering, manufacturing, and suppliers, to ensure quality throughout the product lifecycle. + Ensure compliance with relevant regulations and standards, such as FDA guidelines. + Work with suppliers to ensure they meet quality standards and implement corrective actions for any issues. + Collaborate with supplier representatives on quality problems, ensure effective corrective actions are implemented, and contribute to supplier quality improvement programs. + Assist in the development and validation of new products to ensure they meet quality and regulatory requirements. + Review and deliver First Article Inspections for sustaining parts and development projects. + Develop and implement validation strategies for manufacturing processes to ensure they meet quality standards (IQ, OQ, PQ, TMV, PV). + Design and install sophisticated testing equipment and perform product testing and analysis to maintain quality levels and minimize defects and failure rates. + Analyze reports and defective products to determine trends and recommend corrective actions. + Support receiving, review, and approve PPAP, quarantine/MRB, and manage daily operations. Essential Skills + Supplier quality + Quality engineering + Medical device experience + CAPA (Corrective and Preventive Action) + PPAP (Production Part Approval Process) + APQP (Advanced Product Quality Planning) Additional Skills & Qualifications + Bachelor's degree in engineering, science, or a related field typically required. + Experience in a manufacturing environment, preferably in a medical device or pharmaceutical setting. + 1-2 years of experience for Level I and 3-5 years of experience for Level II. + Strong knowledge of quality management systems, such as ISO 9001. + Certifications such as Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt may be preferred. + Strong analytical, problem-solving, and communication skills. Work Environment This position requires onsite work. The role is an individual contributor position that requires the use of judgment in applying professional expertise. It is expected to work independently with minimal supervision. Standard benefits include 2 weeks of PTO, 10 paid holidays, and other standard benefits. Pay and Benefits The pay range for this position is $50.00 - $65.00/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 Fremont,CA. Application Deadline This position is anticipated to close on May 31, 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. 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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.