Description Investigate product complaints using root cause analysis tools, evaluate potential manufacturing or design issues, leverage Risk Management Files, and consult with clinically trained associates for events within a designated product category Responsible for mentoring other engineering staff in the use of quality tools and root cause investigations. Communicate aggregated data obtained from product evaluations to New Product Development, Product Risk Management, and Commercial Product Teams Maintain detailed and accurate records of complaint investigations, NCMRs, testing methodologies, results, and improvement initiatives. Prepare technical reports for internal stakeholders and regulatory bodies. Analyze and resolve Non-Conformance Material Reports (NCMRs), ensuring timely disposition of non-conforming products. Work closely with Quality Assurance and Manufacturing teams to implement improvements and prevent recurrence. Report post market surveillance data Key Performance Indicators for Management Review within a designated product category Evaluate and optimize manufacturing processes to enhance product performance and consistency. Identify and address process bottlenecks or inefficiencies, implementing solutions aligned with Lean and Six Sigma principles. Develop and execute performance testing protocols for manufacturing processes and finished products, ensuring compliance with regulatory standards (e.g., FDA QSR, ISO 13485). Responsible for writing and execution of in-house process and/or method validations and the SOPs developed. This includes assisting in the design and development of processes and/or measurement system methods and tooling for the test and inspection of the manufacturing process and products. • Collect and analyze performance and quality data from manufacturing processes, customer feedback, and field performance. Use statistical tools to interpret trends and recommend process or product improvements. Responsible for working with suppliers, where necessary, in support of failure investigation activities. Collaborate with cross-functional teams to drive process improvements and implement design-for-manufacturability (DFM) enhancements. Facilitate the implementation of corrective actions identified during investigations or audits. Responsible for assisting in internal and external audits where requested. Responsible for establishing and reporting quality goals and metrics to all levels of the company as well as implementing action plans in a timely manner to meet requirements. Responsible for assisting and mentoring other associates in technical investigations, data handling techniques/analysis, and report writing. Stay informed of regulatory trends and other external expectations regarding product investigations Skills Quality engineering, Root cause analysis, Medical device, Capa, Quality management, Corrective action plans Top Skills Details Quality engineering,Root cause analysis,Medical device Additional Skills & Qualifications Bachelor’s Degree in Engineering or related and minimum 5 years’ experience conducting product complaint investigations, in a regulated industry, using risk management tools Proven experience in a manufacturing or quality role in the medical device industry. Strong knowledge of complaint investigation processes, CAPA systems, and NCMR workflows.• Familiarity with manufacturing process validation (e.g., IQ, OQ, PQ) and device testing standards (e.g., IEC 60601, ISO 14971). Proficiency in statistical analysis tools (e.g., Minitab, JMP) and experience with root cause analysis techniques. Excellent communication and technical writing skills for preparing reports and collaborating with cross-functional teams. Ability to multi-task and manage competing project and business priorities Ability to travel up to 5% Experience Level Intermediate Level Pay and Benefits The pay range for this position is $45.00 - $55.00 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 Irvine,CA. Application Deadline This position will be accepting applications until Jan 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. 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.