Quality Assoc I
Location:
Posted:
October 28, 2016
Reference:
3327290
Job Description :
Every day, Baxter touches the lives of millions of patients and providers worldwide who rely on our essential hospital and renal products and services. You'll find Baxter's products and therapies on nearly every floor, in almost every hospital worldwide, in clinics and in the home. Baxter's employees are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care. Our commitment to our mission means we are there when patients and healthcare professionals need us, during the critical moments that matter most.
Responsible for providing Quality support and oversight via direct staff supervision or process/area responsibilities. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices. Leads ongoing, daily departmental operations. May include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner; Interview/hire, evaluate, train and develop direct reports Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques. Determine the logic, adequacy and effectiveness of processes, systems and related requirements. Develop plans to correct identified risks including areas of non-conformance, inform management and implement approved corrective action plans. Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc. Support external assessments or audits. Assist with audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.) Serve as Subject matter Expert (SME) and provide training to local employees as needed on relevant area(s) Other duties, tasks or projects as assigned.
Summary :
Responsible for providing Quality support and oversight via direct staff supervision or process/area responsibilities.  Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices.  Maintain material release, supplier approval and suppler non-conformances.

Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned) :
  • Leads ongoing, daily departmental operations.
  • May include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner; Interview/hire, evaluate, train and develop direct reports.
  • Drive completion of Supplier Re-evaluations Safety Part Risk, SCARS, and I&D's on timely basis.
  • Monitor effectiveness of SCARs. 
  • Perform supplier and part approvals in the Global Supplier Quality system (GSQ) in TrackWise.  Initiate, review and track Risk Assessment, Mitigation (RAM) and Escalations.
  • Initiate, perform and maintain Reduced testing (item certification and lot monitoring).
  • Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude.
  • Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques. 
  • Determine the logic, adequacy and effectiveness of processes, systems and related requirements. 
  • Develop plans to correct identified risks including areas of non-conformance, inform management and implement approved corrective action plans. 
  • Support continuous improvement objectives, update and maintain metrics.  Identify opportunities for improvement.
  • Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
  • Support internal and external assessments or audits.
  • Assist with audits of various reports (Material release documentation, SCARs, I&Ds, Protocols, Qualifications, Regulatory Submissions, etc.)
  • Serve as Subject matter Expert (SME) and provide training to local employees as needed on relevant area(s).
  • Initiate and own action items in TrackWise CAPA system.
  • Serve as Supplier Quality representative to Mountain Home project teams and others as assigned.
  • MH Quality Representative for JDE E1.  Maintain Supplier Cross reference (GSQTS) supplier # to JDE vendor #.
  • Support alignment of RI raw material inspections versus product use.
  • Must have a working knowledge of Supplier Quality, manufacturing and quality management process and system requirements.
  • Reports and discusses supplier deficiencies and recommendations with appropriate plant management.
  • Must have a working knowledge of supplied raw materials and how materials are utilized in MH processes.
  • Interfaces with all levels of plant management, supervision, employees at all levels, corporate personnel, outside regulatory agencies and material suppliers.

Qualifications :
Job Requirements (Education, Experience and Qualifications ):
  • Bachelor's degree in the physical sciences preferred with one to three years of relevant experience. 
  • Computer proficiency in Microsoft Office applications and ability to use other appropriate software.
  • Must possess a good understanding of the procedures, processes and systems utilized in the operation of the plant.
  • Must possess excellent interpersonal skills and be able to effectively communicate with subordinates, peers, and supervisors.
  • Self-discipline with strong interpersonal communication skills.
  • Must possess exceptional organization skills and ability to plan and implement resolutions to procedural and technical problems.

Physical / Safety Requirements
  • Duties may require overtime work, including nights and weekends
  • Use of hands and fingers to manipulate office equipment is required
  • Position requires standing and walking for extended periods of time 
  • Must be able to perform gowning requirements.
  • Must be able to wear applicable Personal Protective Equipment.
  • Occasional travel as required.
  • Must be able to lift up to 30 lbs.

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.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
Reasonable Accommodations
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.
A little about us:
Our employees are connected by an enduring commitment to save and sustain lives. This higher purpose binds us in doing work that matters.

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