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Quality Engineer II
3 months ago
PURPOSE AND SCOPE: Responsible for Quality Engineering activities including data collection and analysis, specification development and review, product qualification and validation, and design reviews. . Works with cross-functional teams to develop, commercialize, and maintain high quality, innovative and compliant devices by ensuring compliance to design controls, leading and supporting product testing and risk management documentation, generating procedures, and serving as a key resource for associated standards and requirements. PRINCIPAL DUTIES AND RESPONSIBILITIES: Utilizes established work instructions and procedures to perform routine assigned tasks Familiarity with quality records and the ability to write inspection records, specifications and other reports. Familiarity with techniques for assuring data accuracy and integrity. Conducts root cause analysis and corrective action investigations for internal operations. Supports root cause analysis and corrective action for suppliers. Represent the Quality Department on supplier improvements and product changes or supplier partnering programs. Represent the Quality Department on project and process improvement teams. Knowledge of sampling distributions, Binomial, Poisson, Normal and Exponential distributions and be able to apply statistical inference in each. Conducts Correlation and Regression Analysis, Experimental Design (DOE) and acceptance sampling; as well as conducting and interpreting Gage R&R studies. Analyzes data with statistical software and quality tools such as risk analysis, flow charts, control charts, scatter diagrams and histograms and root cause evaluation tools such as 5 why, fishbone diagrams, and Is/Is Not exercised. Operate and troubleshoot Equipment and Disposable products to achieve testing objectives. Applies and incorporates risk management techniques throughout the product life cycle. Maintain general housekeeping of working area and laboratories. Ability to work both independently and as part of a team. Communicates effectively to peers and escalates issues to supervisor/manager for resolution, as deemed necessary. Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations. Assist with various projects as assigned by direct supervisor. Willingness to perform other departmental duties as needed to assist with departmental compliance. Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions. PHYSICAL DEMANDS AND WORKING CONDITIONS: The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must be able to lift and/or move up to 25 lbs. Must be able to stand for long period of time in a laboratory environment. EDUCATION: Bachelor's Degree required. EXPERIENCE AND REQUIRED SKILLS: 3 – 6 years' related experience. Medical device and/or pharmaceutical product experience. Plastics and Fluids product experience. Knowledge of FDA, Health Canada, and ISO13485 as it pertains to medical device and drug requirements. Product shelf-life stability testing… Sterilization, working knowledge… Knowledge of descriptive and inferential statistics, basic probability concepts, Central Limit Theorem, assumptions and robustness of tests, and use of Minitab Ability to read, analyze, compose, and interpret common scientific and technical journals. Assist in the response to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to understand and employ mathematics at an engineering or scientific level. Demonstrated analyzing and troubleshooting techniques to solve problems related to manufacturing processes and product design and use. Strong Computer skills and presentation skills. Strong oral and written communication skills. EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
