Principal Engineer, Sterility Assurance
Are you a highly skilled engineering professional with a passion for ensuring the safety and effectiveness of medical products? Do you possess strong leadership abilities and a deep understanding of sterilization processes? Baxter International is seeking a Principal Engineer to join our Sterility Assurance team. As a key member of our organization, you will play a crucial role in maintaining the quality and sterility of our products, ultimately contributing to the health and well-being of patients worldwide. We are looking for candidates who are driven, detail-oriented, and possess a strong technical background in sterilization and quality assurance. If you are ready to take on a challenging and rewarding role in the healthcare industry, we invite you to apply for this exciting opportunity.
- Conduct research and stay current on industry standards and regulations related to sterilization processes and quality assurance in the medical device industry.
- Develop and maintain sterilization protocols, procedures, and standards in accordance with industry regulations and company policies.
- Lead and manage sterilization-related projects, ensuring timely completion and adherence to budget and quality standards.
- Oversee the validation and qualification of sterilization equipment and processes.
- Collaborate with cross-functional teams, including R&D, manufacturing, and quality control, to ensure the safe and effective sterilization of medical products.
- Conduct risk assessments and implement corrective and preventative actions to resolve any sterilization-related issues.
- Work closely with suppliers to ensure the quality and sterility of materials used in the production of medical products.
- Provide technical support and guidance to other members of the Sterility Assurance team.
- Ensure compliance with all applicable regulations and standards, including FDA, ISO, and other regulatory bodies.
- Participate in audits and inspections, providing necessary documentation and addressing any findings.
- Identify and implement process improvements to increase efficiency and effectiveness of sterilization processes.
- Serve as a subject matter expert on sterilization processes and provide training and guidance to other team members and departments.
- Maintain accurate and detailed records of all sterilization activities and results.
- Monitor and analyze data and trends to identify opportunities for process improvements and optimizations.
- Stay informed of new technologies and innovations in sterilization processes and make recommendations for implementation as appropriate.
Extensive Experience In Sterilization Techniques: A Principal Engineer In Sterility Assurance At Baxter International Should Have A Deep Understanding Of Various Sterilization Techniques, Such As Steam, Ethylene Oxide, And Radiation. They Should Have A Proven Track Record Of Implementing And Optimizing These Techniques In A Manufacturing Environment.
Strong Knowledge Of Regulatory Requirements: As A Principal Engineer, Sterility Assurance, The Candidate Should Have A Thorough Understanding Of The Regulatory Requirements For Medical Device And Pharmaceutical Sterilization. This Includes Knowledge Of Iso And Fda Guidelines, As Well As Global Standards And Regulations.
Leadership And Team Management Skills: The Role Of A Principal Engineer Requires Strong Leadership And Team Management Skills. The Candidate Should Have Experience In Leading And Managing A Team Of Engineers, Technicians, And Other Professionals To Achieve Common Goals.
Problem-Solving And Analytical Skills: A Principal Engineer, Sterility Assurance Should Have Excellent Problem-Solving And Analytical Skills To Identify And Resolve Complex Technical Issues Related To Sterilization. They Should Be Able To Design And Execute Experiments To Gain Insights And Optimize Processes.
Communication And Collaboration Skills: The Candidate Should Possess Strong Communication And Collaboration Skills To Effectively Work With Cross-Functional Teams, Including R&D, Quality, And Operations. They Should Also Be Able To Communicate Technical Information To Non-Technical Stakeholders And Provide Training And Guidance To Team Members.
Data Analysis
Quality Management
Quality Control
Root Cause Analysis
Process validation
Risk assessment
Regulatory compliance
Problem-Solving
Aseptic Processing
Sterility Assurance
Gmp Regulations
Communication
Customer Service
Emotional Intelligence
Leadership
Time management
creativity
Teamwork
collaboration
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Principal Engineer, Sterility Assurance in Round Lake, IL, USA is between $120,000 and $170,000 per year. This can vary depending on factors such as experience, education, and specific job responsibilities.
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Baxter International Inc. is a Fortune 500 American health care company with headquarters in Deerfield, Illinois. The company primarily focuses on products to treat hemophilia, kidney disease, immune disorders and other chronic and acute medical conditions.
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