Around the world, our employees are united by our mission to save and sustain lives. Together, we create a culture that encourages colleagues to pursue rewarding careers -- where everyone has the opportunity to do meaningful work as a part of a team they respect, in an environment that values each person’s contributions. We’re happy you’re interested in continuing your career journey with Baxter.
Essential Duties and Responsibilities
- Lead quality activities for medical and non-medical device software including, change control, risk management, requirements management, field surveillance, investigations, and verification and validation.
- Lead quality activities for legacy products and support audit activities and submissions.
- Lead projects with increased complexity and scope and be required to effectively manage multiple projects with minimal assistance and supervision. May lead a large scale program or several small projects with complex features.
- As required, independently plans, schedules, and leads cross-functional team supporting projects to achieved project objectives and milestones.
- Expected to help establish quality goals and strategy direction for product teams.
Qualifications
- Must have experience or advanced training and demonstrate proficiency in problem analysis and resolution, statistical methods, and design of experiments.
- Proficient in applicable change control and design controls methodology and processes
- Familiar with regulations governing medical and non-medical device software
- Successful track record of managing wide-ranging projects possessing a sense of urgency and commitment to meet project milestones to ensure manufacturing plants and R&D teams achieve targeted goals.
- Extensive cross-functional team experience, including technical and non-technical work.
- The ability to deal with ambiguity and effective use of creative problem-solving skills.
- Embrace Lean Principals and utilize concepts such as standard work to drive continuous improvement.
- Ability to organize and present technical and project management overviews without assistance.
- In addition to their own responsibilities, they will be required to share their experience/knowledge with less experienced engineers in an effort to help mentor them with project assignments and may supervise one or more engineers and/or technicians.
Education and/or Experience
- B.S. in relevant Engineering degree (e.g. Mechanical, Chemical, Biomedical) or Computer Science with a minimum of 5 years of experience working in the field of Product Quality. Experience in the healthcare industry preferred. Criteria can be modified at the discretion of the hiring manager.
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
EEO is the law - Poster Supplement
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 e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.
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