Job Title: Quality EngineerJob Description Investigate product performance issues, drive compliance with regulatory standards, and analyze and optimize manufacturing processes. Address customer complaints, non-conformance reports (NCMRs), Corrective and Preventative Action reports (CAPAs) and other quality concerns. 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. Establish and report quality goals and metrics to all levels of the company, and assist and mentor other associates in technical investigations, data handling techniques/analysis, and report writing. Responsibilities + Investigate product performance issues. + Drive compliance with regulatory standards. + Analyze and optimize manufacturing processes. + Address customer complaints, NCMRs, CAPAs, and other quality concerns. + Collect and analyze performance and quality data from various sources. + Use statistical tools to interpret trends and recommend improvements. + Establish and report quality goals and metrics. + Assist and mentor associates in technical investigations and report writing. Essential Skills + Quality engineering + Root cause analysis + Medical device experience + Complaint handling + CAPA + Technical writing + Investigation and analysis + Quality control + Experience with investigations, Minitab, Lean Six Sigma, chemistry, audit, supplier quality, and quality assurance Additional Skills & Qualifications + Bachelor’s Degree in Engineering or related field + Minimum 5 years’ experience conducting product complaint investigations in a regulated industry + Proven experience in 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, ISO) + Proficiency in statistical analysis tools (e.g., Minitab, JMP) + Excellent communication and technical writing skills + Ability to multi-task and manage competing project and business priorities + Ability to travel up to 5% Work Environment Medical device manufacturing - global leader in breakthrough cardiovascular and endovascular solutions. Team size of 8. Hours M-F 8:00 - 5:00 but flexible, also open to earlier or later start times (e.g., 6:00 - 3:00, 9:00 - 6:00). Limited OT expected. Collaborative, fast-paced medical device manufacturing environment. Pay and Benefits The pay range for this position is $44.00 - $59.00/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 Irvine,CA. Application Deadline This position is anticipated to close on Feb 15, 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.