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Quality Engineer

Req #: 180006YE_en
Location: Castlebar, C IE
Job Category: Quality
Date Posted: 4/10/2018 6:28:39 AM
Baxter International

Description

About Baxter
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre 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.
 
 
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.
 
The Role
As a Quality Engineer, you will provide technical support, coordinate activities and projects for the CAPA investigation system and ensure compliance with established standards and regulations.
 
Responsibilities
  • Review and approval of S/NC and CAPAs, with attention to detail, review for completeness, accuracy, effectivity and timeliness.
  • Liaise with relevant functional groups, facilitate and mentor teams through all stages of the NC /CAPA process.
  • Apply problem solving methodology to facilitate and coach NC & CAPA teams in the application of problem solving techniques and promote its use and development.
  • Subject matter expert on all related procedures, ensuring compliance to the relevant corporate procedures.
  • Manage and monitor NC/CAPA KPI’s including reporting requirements, provide detailed updates and information in support of quality and business review forums.
  • Ensure adequate training is developed, maintained and provided to all users of CAPA process and systems.
  • Take a lead role and participate in cross-plant and corporate project teams in areas of CAPA and quality systems improvement.

Qualifications

  • Bachelor Degree in Business Administration or Science related discipline.
  • Strong relevant experience, with healthcare sector experience a plus.
  • Previous experience working in a GMP regulated environment desired.
  • Proven ability to work as a member of a team, as well as independently.
  • Ability to communicate in a clear and concise manner.
     

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, colour, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.

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