Quality Engineer I, QA Systems at Baxter… · St Paul

Summary: Baxter International Inc. is committed to redefining healthcare delivery and improving lives. The Quality Engineer will support manufacturing and new product development through quality engineering activities, including investigations, qualifications, and validations, while ensuring compliance with quality standards. Responsibilities: - Responsible for Nonconformance and CAPA activities. Investigate and disposition nonconforming materials. Initiate, investigate, and implement corrective and preventive actions as assigned. Perform internal quality system and supplier audits, as assigned - Responsible for site quality support of manufacturing operations including attending Tier Meetings, Engineering Investigations, writing Qualification and Validation plans, statistical analysis of data and preparation of reports - Support manufacturing improvements, on-going validations, and new product development efforts - Initiate documentation or documentation changes (DCRs, Deviations, etc.) for products and processes as required to reflect validation/qualification activities and results - Complaint investigations as assigned by Product Surveillance or Supervisor - Support product development teams to develop new products and transfer to manufacturing through participation/leadership of risk management activities, performance of component qualifications, and execution of test protocols - Other duties as assigned Required Qualifications: - BS in Engineering or related field of science - 1+ years of experience in Manufacturing Quality, Design Assurance or Quality Systems - Experience managing non-conformance activities and owning corrective and preventative actions - Must have the ability to read/interpret design prints - Working knowledge of FDA GMP and ISO 13485 requirements - Knowledge of statistics and quality tools such as SPC, Risk Analysis, Process Capability, DOE, TQM methods, and Lean/Six-Sigma Preferred Qualifications: - Sterilization and Process Validation experience - ASQ Certification in Quality Engineering - Previous Quality System auditing experience Required Skills: Nonconformance management, Corrective, preventive actions (CAPA), Design print interpretation, FDA GMP, ISO 13485, Statistics, Statistical Process Control (SPC), Risk Analysis, Process Capability, Design of Experiments (DOE), Total Quality Management (TQM), Lean, Six Sigma, Sterilization, Process Validation, Quality System auditing, ASQ Quality Engineering Certification Benefits: 401K, Medical and dental coverage that start on day one, Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance, Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching, Flexible Spending Accounts, Educational assistance programs, Paid holidays, Paid time off ranging from 20 to 35 days based on length of service, Family and medical leaves of absence, Paid parental leave, Commuting benefits, Employee Discount Program, Employee Assistance Program (EAP), Childcare benefits