Quality Engineer II

The Quality Engineer II will utilize and maintain quality engineering systems and practices in collaboration with Agiliti manufacturing and design centers that meet and exceed internal, customer, and regulatory requirements. PRIMARY DUTIES AND RESPONSIBILITIES Perform quality engineering tasks for new & existing products and process development and improvement initiatives. Applies systematic problem-solving and SPC methodologies in identifying, prioritizing, communicating, and resolving quality issues. Develops and maintains product control plans and inspection methods for raw materials, materials in process, and final release. Collaborates with Design, Manufacturing, and Supply Chain teams to monitor supplier performance. Monitor and analyze supplier performance data, detecting trends, and collaboratively addressing any deviations or issues with suppliers. Collaborates in planning, execution, and maintenance of equipment validation activities. (IQ, OP and PQ) Participates in and may lead plant Material Review Boards (MRB) to assist with investigations and disposition of product nonconformances. Lead review activities to maintain medical device files, resulting from engineering change orders, such as Risk Management, Process FMEA, and Quality Control Plans. Participates in execution of verification and validation protocols. Participates in projects and cross functional teams. May lead mid-scale projects. Lead CAPA investigations and action item implementation. EXPERIENCE Bachelor’s Degree (BS) in Engineering, Scientific, or Technical related subject required. 3-5 years of relevant experience, preferably in an medical device manufacturing environment. Working knowledge in New Product development Experience in FDA 21 CFR Part 820 Quality System Regulation required. Experience in ISO 13485:2016 Medical Devices required. Experience in ISO14971 Risk Management preferred, but not required. Experience with metrology equipment and lab preferred, but not required. Experience in electronics or PC Board manufacturing environment desired. Experience with working and qualifying automation equipment. Use of statistical analysis software for SPC & CPk Analysis Tooling and fixturing qualification experience (FAI and Gage R&R) SKILLS & ABILITIES Bilingual in Spanish is a plus. Proficient computer skills in MS Office Suite, including MS Project and Visio. Working knowledge of CAD software preferred (i.e., SolidWorks, Autodesk, etc.) Strong analytical skills and attention to detail Strong technical writing skills and effective communication skills Strong presentation, facilitation, and project management skills This job description in no way states or implies that these are the only duties to be performed by the employee in this position. It is not intended to give all details or a step-by-step account of the way each procedure or task is performed. The incumbent is expected to perform other duties necessary for the effective operation of the department. It is the policy of Agiliti to provide equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender identity, sex, sexual orientation, national origin, age, physical or mental disability, genetic information, marital status, status as a veteran, military service, or any other characteristic protected by applicable federal, state, or local civil rights laws. In addition, Agiliti will provide reasonable accommodations for qualified individuals with disabilities. Agiliti strictly prohibits any form of retaliation against individuals who make good faith reports of alleged violations of this policy or who cooperate in Agiliti’s investigation of such reports. Affirmative Action Policy Statements (https://www.agilitihealth.com/wp-content/uploads/AAP-Statements.pdf) You may be required to obtain certain vaccinations, or provide proof of current vaccination status, based on customer and/or company requirements. If vaccination is required, Agiliti will provide specific directions and cover the expense at a participating clinic. Please note, this includes the COVID-19 vaccination. Agiliti offers a robust suite of benefits for regular, full-time, non-union employees including: health insurance options for Medical, Dental & Vision plans, Short- and Long-Term Disability plans, Flexible Spending Accounts, Health Savings Accounts, Life Insurance Options, Paid Time Off, 401K Saving Plan with employer match, Employee Discounts, Tuition Reimbursement, Daily Pay program, Employee Assistance Program, and wellness programs. Agiliti is an equal opportunity employer and provides reasonable accommodations to employees and applicants consistent with state and federal law. If you require assistance with your application, please contact recruiting@agilitihealth.com. Primary Job Location: Corona CA Branch Additional Locations (if applicable): Job Title: Quality Engineer II Company: Agiliti Location City: Corona Location State: California Pay Range for All Locations Listed: $87,085.99 - $139,463.03 This range represents the low and high ends of the Agiliti pay range for this position. This base pay range information is based on the market locations shown. The actual pay offered may vary depending on several factors including geographic location, experience, job-related knowledge, skills, and related factors. Dependent on the position offered, short-term and/or long-term incentives may be provided as part of the compensation. Applicants should apply via Agiliti's internal or external career site.