Quality Engineer II

Essential Job Duties and Responsibilities * Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements * Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements * Coach and mentor non-exempt personnel * Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues * Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues * Design and conduct experiments for process optimization and/or improvement * Appropriately document experiment plans and results, including protocol writing and reports * Lead process control and monitoring of CTQ parameters and specifications * Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing) * Lead the investigation, resolution and prevention of product and process nonconformances and customer complaints * Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member) * Lead in the completion and maintenance of risk analysis * Work with design engineering in the completion of product verification and validation * Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements. * Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. * Performs other related duties and responsibilities, on occasion, as assigned. * Coach and mentor non-exempt personnel Education and Experience Requirements * BS degree in Engineering or Technical Field or equivalent experience; advanced degree preferred * 3+ years' experience * ASQ CQE or other certifications preferred * Prior medical device experience preferred * Engineering experience and demonstrated use of Quality tools/methodologies * Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing) * Experience participating in Quality System audit preferred * Experience working in a broader enterprise/cross-division business unit model preferred. Skills and Abilities * Knowledge of FDA, GMP, and ISO 13485 * Solid communication and interpersonal skills * Advanced computer skills, including statistical/data analysis and report writing skills Working Conditions and Physical Demands To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Travel Required Minimal Nordson Corporation provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status or any other status protected by applicable federal, state, or local law. All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.