Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.1. Coach Tier I and Tier II CAPA Owners to assure documents meet Baxter requirements:
- Issue is investigated to root cause
- Actions taken are effective at mitigating or eliminating root cause
- Investigations and actions are timely
- Documents are well-written and audit ready
2. Own key Tier I and Tier II CAPAs and with guidance, schedule and lead team through the planning and execution of an investigation, corrective action and effectiveness check.
3. Coordinate CAPA Review Board presentations.
4. Be directly involved in and where appropriate lead process improvement projects which may include any of the following: Kaizen, Value Stream Maps, development of new processes/quality systems, improving existing
products/processes/quality systems, report development and presentation.
5. Ability to independently prioritize assigned tasks based upon project and overall business needs.
- Strong analytical, problem solving and technical writing skills.
- Strong organizational, communication and interpersonal skills. Both strong verbal and written communication skills required.
- Strong attention to detail.
- Must possess quality assertiveness and independent decision making skills.
- Demonstrated ability to work effectively within a matrix-managed organization and influence activities without direct functional responsibility.
- Knowledge of FDA, ISO and MDD regulations.
- Experience with standard software tools such as MS Office Excel/Word/PowerPoint) and Microsoft Project.
Education and/or Experience
- Bachelor's degree or MS in Engineering discipline
- 5 or more years relevant work experience in Quality or related field in the medical products industry
- Project Management experience in a matrix organization preferred.
Physical Demands/Working Environment
Office working conditions, no specific physical requirements
Baxter provides its employees with comprehensive compensation and benefits.To view other opportunities at Baxter and to learn more about the company, please visit our Web site at http://www.baxter.com/about_baxter/careers . EOE M/F/D/V.
