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Quality Lead

Req #: 1800045Q_en
Location: Round Lake, IL US
Job Category: Quality
Date Posted: 2/25/2018 7:02:24 PM
Baxter International


About Baxter
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.


Responsible for all aspects of external supplier management related to specified products in the advanced surgery business.  Manage supplier qualification and evaluations to assess compliance and risk.  Manage product release processes and ongoing relationship with suppliers.  Is responsible for results in terms of compliance and/or product quality and conformance to regulations and Baxter quality policies.  


Essential Duties and Responsibilities

  • Responsible for all aspects of external supplier management related to specified advanced surgery products.

  • Review and approve manufacturing records for products manufactured by Contract Manufacturing Organizations to ensure accuracy and completeness.  This may include a review of non-conformance reports related to the manufacturing of these products.

  • Perform reviews of records and complaint history queries for complaint reports received for these products.

  • Execute routing change control packages related to Baxter products manufactured by Contract Manufacturers.

  • Oversee Quality Agreements between suppliers and Baxter.

  • Manage Quality and Compliance related issues between suppliers and Baxter.
  • Participate in or manage quality assessments of internal operations and suppliers to assess compliance and risk.

  • Oversee quality risk assessments; ensure mitigation actions and follow-up on CAPA implementation and drive quality/process improvement initiatives at the suppliers.  Monitor and report quality performance metrics, as applicable.
  • Oversee change implementation process, deviation/investigation review and CAPA closures by Baxter suppliers.
  • Work with Baxter employees across multiple global sites and functions to assess the impact of supplier changes and/or risks.
  • Understands and ensures conformance to regulations applicable to several sections or departments.

  • Interacts frequently with internal subordinate supervisors, functional peer and senior group managers.

  • Manages interactions with regulators and customers to represent the company products and processes.

  • Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements.


Qualifications for this role 

  • Strong quality orientation required. Knowledge of cGMP, global regulatory guidelines, and validation practices.
  • Qualified auditor.
  • Experience in Supplier Quality Management or External Contract Manufacturing required.
  • Experience with biologic products strongly preferred.
  • Strong analytical skills and a proven track record in solving complex problems to support product quality impact assessments and lot disposition (release/reject) decisions.
  • Effective communicator at all levels both internally and externally; excellent written, oral, and interpersonal communication and presentation skills
  • Experience with medical product quality and compliance management systems
  • Ability to travel 40% of the time. 
  • Thorough knowledge of applicable procedures, specifications, regulations and standards.
  • Strong project management skills.

A Career That Matters
Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.

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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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 e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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