Baxter is looking to ensure that its suppliers continue to enable its Mission by providing high quality, safe, and effective products, and is seeking a Supplier Quality Assurance Lead to oversee this process.
Requirements
- Experience in root cause analysis, corrective and preventive action methods
- Expertise/experience in problem solving with quality tools such as: 6-sigma / 8-D / CAPA / FMEA / 5WHY etc.
- Experience with data analysis and reporting using basic Excel toolkit and advanced statistical /process packages such as Minitab or Visio and PowerPoint
- Knowledge of medical device regulations, e.g., ISO 13485, FDA cGMP, other global or regional equivalent
- Working knowledge of US and International cGMP
- Experience in Product/process development and/or supplier quality improvement
- Auditing skillsets, up to and including certified SQ lead auditor training
Responsibilities
- Improve/develop quality systems at selected suppliers for QMS and product quality improvement
- Execute SCAR management, effective and timely closure and review/risk assessment of supplier quality notifications and their escalation to SCARs and NCR where needed
- Collect, trend and report supplier performance metrics
- Manage and oversee Supplier CAPA, including root cause identification, and effective and timely closure
- Develop and/or deliver training and process improvement to internal teams and suppliers
- Perform qualification of component and medical device, combination device suppliers
- Conduct and oversee supplier audits-qualification and re-qualification, including finding closure
Other
- Bachelor's degree in life sciences or engineering
- Requires 5+ years of experience in Quality, Manufacturing, Engineering or related field
- Willingness to travel within North and South America (up to 40%)
- Ability to manage the quality relationship with assigned key suppliers/stakeholders
- Applicants must be authorized to work for any employer in the U.S.
