Mgr II, Quality (Risk Management)
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
Essential Duties and Responsibilities:
This position will drive Quality System Elements and Interconnectivity govering Risk Management, Recalls, Risk-Based Trending, Material Control and their relationship to Complains, CAPA, and FAR/MDR reporting.
This position will be responsible for ensuring that these processes meet the following criteria:
Are executable by users including training and support of those users
Satisfy the needs of the business
Consider the needs of internal and external stakeholders
Eliminate non-value added work
Drive focus on the critical work
The position requires significant experience in the following areas:
Design of Quality System Process
Design of Lean Processes and Systems
Voice of the Customer Techniques
Deep knowledge of Listening Systems, Risk Management, Trending, Product knowledge, Product Use Knowledge.
- In depth knowledge of the regulatory environment for manufacture of medical products.
- Good relationship skills and demonstrated success managing in a matrixed environment as a individual contributor. Ability to develop business and team relationships
- Strong analytical ad problem solving skills
- Good verbal and written communication skills
- Experience working with multifunctional, global teams
- Good interpersonal, communication, influencing, negotiation skills
- Demonstrated problem solving skills
- Ability to independently develop strategic and implementation plans for Quality System Processes
- Project Management skills to execute changes and ensure sustainability
Education and Experience:
- BS in science or engineering; advanced degree helpful.
- 7 years of experience in Quality, Manufacturing, Engineering or related field preferred.
- 5 years of management experience preferred.
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.
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.