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Lead, EMEA Quality Systems & Compliance

Req #: JR - 060117 Location Marsa, Il-Marsa, Malta Job Category: Quality Control Date Posted: 03/29/2022

Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

  • Support for Parents

  • Continuing Education/
    Professional Development

  • Employee Health &
    Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

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Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Detail Oriented
  • Continuous Learner
  • Courageous
  • Collaborative
  • Critical Thinker
  • Influential

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Lead, EMEA Quality Systems & Compliance

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Summary

The role will be managing and supporting quality systems and compliance activities for the region EMEA (Europe Middle East and Africa). This includes support to the sites reporting in EMEA and support to the legal manufacturer (BHSA) for the CE marked medical devices. This includes:

  • Support to the compliance of the sites and of BHSA to the medical device regulation (EUMDR)
  • EMEA ISO13485/MDSAP (Medical device single audit program) certification management
  • BHSA Legal manufacturer compliance support (support during audits, transfers, Management review preparation, interaction with manufacturing sites, Global functions)
  • Participate and support Regional and Global Compliance initiatives and projects.
  • Support the internal audit program (global/regional)

Essential Duties and Responsibilities. 

  • EMEA ISO13485/MDSAP certification oversight
  • Oversee ISO/MDSAP audit planning
  • Control ISO/MDSAP certificates scope, align with BHSA as needed
  • Ensure sterilization audits planned and performed
  • Communicate with Notified Bodies (TUV, BSI) for the ISO and MDSAP related questions
  • Manage EMEA ISO/MDSAP change notifications
  • Escalate any issues raised during audits
  • BHSA legal manufacturer compliance support
  • Implement and maintain BHSA interaction oversight with all functions per procedure EMEAQS010
  • Escalate any compliance risk related to BHSA management
  • Prepare analysis of sites performance for BHSA management review
  • Oversight of key process indicators (KPI’s): change controls, NCRs/SNCRs and other indicators
  • Support the certification of BHSA to regulations/directives (ISO13485/MDSAP/MDD/EUMDR)
  • Perform risk management activities for BHSA
  • Support BHSA external audits
  • Compliance to Global QMS and regulations in Region EMEA:
    • Support EMEA entities to ensure and improve compliance
    • Drive regional improvement projects on selected processes
    • Support sites with inspection readiness (participate in external audits, train sites etc)
    • Perform internal, mock up, ad hoc audits as required

Other roles include:

  • Keep EMEA sites informed about all regulations which impact EMEA sites (manufacturing sites, CQA central functions, etc)
  • Increasing amount of adequacy checks for CAPA, training sessions, entity support, interplant CAPA assessments, increase % PA oversight

Qualifications

  • A degree in life-science or Engineering, Pharmacy, or equivalent degree in the scientific field
  • 2 years industry experience in Pharmaceutical or Medical device related industry. Baxter experience preferred
  • Excellent level of English (Spoken, Read, Written): interviews will be performed in English
  • Use of Word/Excel/Power Point is a must
  • Thorough knowledge of ISO9001 or ISO13485 requirements
  • Project management skills
  • Quality System processes knowledge and experience (particular experience in Change control process is a plus)
  • Critical thinking and the ability to challenge the status quo
  • Have a pragmatic approach, hands-on attitude
  • Strong analytical/problem solving skills
  • Ability to work in an international and matrix environment with different tasks
  • Results oriented with a process and quality driven approach
  • Self-driven with the ability to work independently as needed
  • Excellent team-work and collaboration skills
  • Strong communication skills: needs to cascade information both ways and ensure consistent, concise, clear messages to all, influence others skills
  • Eagerness to learn, strong motivation
  • Positive approach, optimism

Education and/or Experience. 

  • Degree in engineering, pharmacy, natural science or equivalent degree in scientific field.
  • A minimum of 2 years of experience in a relevant position in quality or regulatory in a strongly regulated industry.
  • Experience in supporting Quality Systems / compliance

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 [email protected] and let us know the nature of your request along with your contact information.

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060117

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Christelle, Senior Quality Manager in Malta

"I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need."

Christelle

Meet Lorena, Senior QA Associate in London, UK

"I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety."

Lorena

Meet Gary, Quality Research Manager in Singapore

"I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission."

Gary

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Christelle

Meet Christelle, Senior Quality Manager in Malta

"I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need."

Lorena

Meet Lorena, Senior QA Associate in London, UK

"I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety."

Gary

Meet Gary, Quality Research Manager in Singapore

"I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission."

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