Lead, SQ AssuranceReq # JR - 016369 Location Round Lake, Illinois, United States Job Category Quality Control Date posted 02/15/2020
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Define and monitor Quality system requirements to suppliers within the Finished Good and Contract Manufacturing space
Essential Duties and Responsibilities
- Set Quality system requirements to suppliers within the Finished Good and Contract Manufacturing space
- Perform Qualification of suppliers of medical device, pharmaceutical, combination devices, and/or biologics standards and oversee their placement on the Approved Supplier List (ASL), including ensuring the creation and maintenance of supporting evidence (Supplier Master File)
- Conduct and oversee supplier audits-qualification and re-qualification, including finding closure; Collect, trend and report supplier quality metrics
- Oversee and negotiate Quality Agreements between suppliers and Baxter.
- Improve/develop quality systems at selected suppliers for QMS and compliance improvement
- Develop purchasing controls processes, procedures and systems, including those for BOM, non-BOM, services, spare parts and Third Party Finished Goods
- Evaluate and improve the effectiveness of purchasing controls and supplier quality processes and procedures, including Quality Agreements
- Assist in preparing for and defending Purchasing Controls in inspections by external agencies or internal Baxter audits of Purchasing Controls processes; Manage and oversee Purchasing controls CAPA, including root cause identification, and effective and timely closure
- Develop and/or deliver training to internal teams and suppliers.
- Execute SCAR management, effective and timely closure and Review/risk assessment of Supplier Quality Notifications and their escalation to SCARs and NCR where needed Accountable for NCR as assigned, conducting NCR timeliness and effectiveness reviews, and trending for corrective/preventive actions,
- Support Manufacturing, Regulatory, Quality and Purchasing organization for third party suppliers related activities, as applicable.
- Collaboration and Teamwork: Good communications, facilitation, coordination and team skills
- Project management skills managing multiple issues of moderate to high complexity relatively independently with minimal supervision/instructions
- Ability to manage the Quality relationship with assigned key suppliers/stakeholders - Competence in supporting on-site/off-site supplier quality development including coordination/management of resources
- Multi-tasking skills in a demanding fast paced environment
- Superior time-management skills
- Attention to details and a passion for quality
- Superior written and oral communications skill sets - Willingness to travel (up to 50%)
Education and/or experience
- Higher level of technical education (e.g., Science degree, Diploma, or Alternative); Engineering degree preferred.
- Requires 7+ years of experience in Quality, Manufacturing, Engineering or related field; electromechanical industry experience needed.
- Experience in other related finished good experience a plus (e.g., automotive, aerospace, combination products, pharmaceuticals)
- Manufacturing experience is required in electromechanical industry; knowledge of populated circuit boards, power supply, monitors, hardware.
- Experience auditing manufacturing facilities
- 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.
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.
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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.