Senior Quality Engineer - Operating Room (Post Market)

Job Summary Under minimal supervision, responsible for independently setting basic quality standards for both in-process and design control, leading efforts to develop methods for testing, sampling, and training. Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain DMR’s, product specifications, design control files and CE technical files. Responsibilities Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing and inspection to ensure that products are ideal and functional. Design complex experiments to understand sources of variation affecting products and processes. Apply statistical process control (SPC) methods for analysing data to evaluate the current process and process changes. Design and perform experimental product testing and analysis to maintain quality levels and minimise defects and failure rates. Generate and analyse reports and defective products to determine trends and lead corrective actions. Use concepts of probability and statistical quality control to guide decisions. Direct and collaborate with supplier representatives on quality problems, ensure that effective corrective actions are implemented (CAPA, SCAR) and contribute to supplier quality improvement programmes. Lead supplier qualifications. Provide quality expertise in product development, design control activities, risk management and CE technical files. Build appropriate product documentation (e.g. Device Master Records) in compliance with applicable regulations. Work with regulatory groups and suppliers to produce 510(k) submissions, letters to file and other required documents. Coordinate product testing with internal and external laboratories as required. Ensure compliance with domestic and international regulations associated with product lines and processes. Perform quality reviews of design documentation for compliance with stated requirements, including vendor quality documents and company quality records. Lead investigations of product and process non‑conformances and out‑of‑specification results and develop effective corrective and preventive actions (CAPA). May train and coach team members and Medline employees on appropriate processes and best practices. Act as quality lead in the absence of quality management. Qualifications Education: Bachelor’s degree in Engineering, Science, Math or other related technical field. Work experience: At least 4 years of experience in quality or engineering. Experience applying knowledge of government and industry quality assurance codes and standards (e.g. 21 CFR 820, ISO13485, 21 CFR 210 and 211, MDD/MDR, and ANSI/AAMI/ISO sterilisation standards). Knowledge and experience of developing ways of accomplishing goals with little or no supervision. Experience using time‑management skills to prioritise, organise and track details to meet deadlines of multiple projects. Experience in problem‑solving, overcoming obstacles and reaching a positive and successful solution through mathematical or systematic operations. Experience leading a team to accomplish cross‑functional goals. Experience using MS Office Suite products (Word, Excel, PowerPoint and Outlook). Advanced skill level in Microsoft Excel (pivot tables & pivot reporting, conditional formatting, tables, formulas, charting). Position requires up to 15% travel. Preferred Qualifications At least 5 years of industry experience in medical devices, drugs and/or fields directly related to the role. Knowledge of advanced Six Sigma/Lean concepts. Compensation & Benefits The anticipated salary range for this position is $101,000.00 – $152,000.00annual. The actual salary will vary based on applicant’s location, education, experience, skills and abilities. This role is bonus and/or incentive eligible. The benefit package includes health insurance, life and disability insurance, 401(k) contributions and paid time off for employees working 30 or more hours per week on average. For employees working less than 30 hours per week, benefits include 401(k) contributions and paid time off, as well as access to the Employee Assistance Programme, Employee Resource Groups and the Employee Service Corp. Equal Employment Opportunity Statement Medline Industries, LP is an equal‑opportunity employer. Medline evaluates qualified individuals without regard to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information or any other characteristic protected by applicable federal, state or local laws. #J-18808-Ljbffr Medline Industries, LP