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.
- Support external audits and MOH commitments.
- Proactively assess planning and execution of MOH commitments.
- Prepare and issue reports based on status and resolution of MOH commitments.
- Conduct QC reviews of documents to ensure compliance with SOPs.
- Ensure regulatory compliance of the quality system procedures relating to Product Holds, Field Corrective Actions and CAPA.
- Ability to lead and/or own a CAPA (formal problem solving).
- Assess CAPA execution and drive sustainability.
- Partner with corporate QA organizations in ensuring compliance to the Quality System.
- Provide training as required to ensure compliance to SOPs and regulations.
- Manage engineering staff as needed.
- Prepare and issue reports concerning quality metrics.
- Determination of key quality metrics.
- Minimum 8-10 years experience in a medical device environment or regulated industry.
- 3-5 years experience with CAPA.
- 3-5 years experience with risk management (specifically Hazard Analysis and FMEA).
- Knowledge of FDA, ISO, and MDD regulations.
- Project management skills.
- Technical writing skills.
- Bachelor’s degree in Engineering or Science.
- Ability to review/edit technical documents.
- Excellent organizational skills.
- Ability to interface with multiple functional groups.
- Manufacturing experience preferred.
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.
