Every day, Baxter touches the lives of millions of patients and providers worldwide who rely on our essential hospital and renal products and services. You'll find Baxter's products and therapies on nearly every floor, in almost every hospital worldwide, in clinics and in the home. Baxter's employees are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care. Our commitment to our mission means we are there when patients and healthcare professionals need us, during the critical moments that matter most.
The Principal Software Quality Engineer works as a member of one or more project teams by being engaged in new product development and/ or sustaining products for medical device and/ or commercial systems. This individual will serve as a quality representative on the software project team and will work closely with the Core Team Leader and is responsible for ensuring that each project is developed and released meeting customer expectations and regulatory requirements. He/She will work closely with product engineering to ensure robust requirements, successful design, development, verification and validation testing, design transfer, change control management and will also provide support to product software sustaining engineering.
Knowledge/Qualifications needed for this role:
- Design and Development Planning
- Development of Technical Requirements and Product Specifications
- Risk Management/ FMEA
- Design Verification and Design Validation
- Statistical Analysis
- Design Reviews
- Design Transfer Activities
- Design History File Management
- Complaint Management
- CAPA and FCA
- Experience on a product development team releasing software product to market for a highly regulated industry. Medical device preferred.
- Thorough understanding of regulations, standards, guidance documents and best practices for software development in a highly regulated industry (Medical device preferred: specifically 21 CFR Parts 820, 803, & 806, ISO 13485, ISO 14971 and IEC 62304)
- Demonstrated knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc.)
- Detailed knowledge of software development, quality assurance and verification and validation testing
- Thorough understanding to manage software issue/ complaint investigations, CAPA and FCA assessments
- In-depth understanding of software development lifecycle phases.
- Experience with FDA inspections. ISO/ Notified Body audits is a plus
- Ability to work at Senior Management levels
- Strong communication and leadership skills.
- Strong, results driven, project management skills
- Excellent problem solving skills and the ability to teach others
- Professional certification such as ASQ, IEEE, Six Sigma, LEAN manufacturing or achievement of certification within two years. ASQ CSQE preferred.
Education and Experience
- Bachelor's degree in Engineering or Computer Science plus 5-8 years of experience or MS Engineering with 3-6 years of experience or Ph.D. Engineering with 0-3 years of experience in a highly regulated industry such as FDA, DoD, aerospace, telecom, or nuclear with a thorough understanding of the regulations, standards, SDLC and quality management systems.
#LI-BB1-P Equal Employment Opportunity
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.
EEO is the Law
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Pay Transparency Policy Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an email to Corporate_Staffing_Deerfield@baxter.com or call 877-229-4748 (877-BaxHR4U) and let us know the nature of your request along with your contact information.
A little about us:
Our employees are connected by an enduring commitment to save and sustain lives. This higher purpose binds us in doing work that matters.