Sr Engineer, Quality

Senior Quality Engineer

The Senior Quality Engineer provides engineering support to the plant through process optimization, risk management, validation, defect prevention, project management, and technical evaluations. This role ensures compliance with GMP, QSRs and all applicable standards related to product/process validation.

• Lead or assist in developing and implementing new machines, processes, or computer systems, and in improving existing methods.
• Define requirements for new or improved machines/processes/computer systems, including system requirements, design specification, risk analysis, installation qualification, operational qualification and performance qualification.
• Interface with local Quality, Production, Engineering, and Corporate Engineering, Quality and Regulatory functions.
• Support the manufacturing plant through the implementation of process improvements and conduct process/financial analysis using ROI, quality trending, MIP measurements and other conventional methods.
• Manage small projects, including cost, change management, implementation and validation.
• Lead cross‑functional teams.
• Lead ongoing validation and verification programs such as Continuous Process Verification (CPV), Validation Master Plans, Periodic Reviews, Computer Systems Validation, Stability programs and Calibration.
• Perform statistical analysis to support Quality and Production.
• Evaluate sampling, testing and qualification plans with respect to current quality levels and test methods.
• Compose protocols, final reports, studies, experiments and general information reports for management.
• Route documents in the Document Management System.
• Lead and coordinate validation efforts of new equipment and changes to existing equipment.
• Assist in the evaluation of customer complaints, risk management, technical summaries and supplier product/process changes.
• Ensure compliance of manufacturing and quality control operations with corporate specifications, SOPs, GMP, ISO
  13485 and other applicable standards.
• Apply engineering, statistical/six sigma tools to identify opportunities for improvement.
• Support, review and approve, and may own execution of CAPA investigations using DMAIC and technical writing skills.
• Maintain a safe work environment.

• Minimum 3 years of experience in a regulated manufacturing environment.
• BS degree required, preferably in Engineering;
  Engineering Technology, Microbiology or Chemistry acceptable.
• Experience leading cross‑functional teams.
• Computer proficiency in Microsoft Word, Excel, Outlook and enterprise software (e.g., JDE, BPLM, POMs, Maximo).
• Familiarity with MINITAB.
• Strong technical writing, investigative and communication skills.
• Knowledge of international standards such as ASTM, ASRAE, ANSI, AAMI, ISO.
• Ability to identify problems, initiate and implement solutions to prevent nonconformities.

Estimated base salary: $96,000 - $132,000 annually.

• Medical and dental coverage starting day one.
• Basic life, accident, short‑term and long‑term disability, and business‑travel accident insurance.
• Employee Stock Purchase Plan (ESPP).
• 401(k) retirement savings plan with company matching.
• Flexible Spending Accounts.
• Educational assistance programs.
• Paid holidays and PTO (20–35 days based on length of service).
• Family and medical leave, and paid parental leave.
• Commuting benefits.
• Employee Discount Program.
• Employee Assistance Program (EAP).
• Childcare benefits.

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.