Associate - EMEA Supplier Quality

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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 Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

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

Associate - EMEA Supplier Quality

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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.

Duties & Responsibilities

Set quality system requirements for suppliers within the employee’s defined commodity portfolio.
Perform Qualification of suppliers to 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. Oversee and negotiate Quality Agreements between suppliers and Baxter.
Assess and process changes induced by the supplier and / or Baxter. Evaluate and improve the effectiveness of purchasing controls and supplier quality processes and procedures; Collect, trend and report supplier quality metrics.
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 when needed, effective and timely closure and Review/risk assessment of Supplier Quality Notifications and their escalation to SCARs and NCR where needed.
Accountable for NCR (non-conformance reports) as assigned, conducting NCR timeliness and effectiveness reviews, and trending for actions.
Support Manufacturing, Regulatory, Quality and Purchasing organization for third party suppliers related activities, as applicable.

Qualifications

Knowledge of pharmaceutical and/or medical device regulations, e.g., ISO 13485, ISO 9001, FDA cGMP, international cGMP, MDD, MDR, Eudralex, other global or regional equivalent as it applies to the defined commodity portfolio.
Working knowledge of US cGMP is advantageous. Experience in Product/process development and/or supplier quality improvement.
Auditing skillsets, up to and including certified SQ lead auditor training; Quality Management System auditing, and where possible, special process auditing skills. Knowledge of Business Acumen; knowledgeable in current and possible future policies, practices, trends, technology, and information affecting his/her industry, business and organization. Collaboration and Teamwork: Good communications, facilitation, coordination and team skills.
Project management skills managing multiple issues of moderate to high complexity relatively independently.
Ability to manage the Quality relationship with assigned key suppliers.
Competence in supporting on-site/off-site supplier quality development including of resources.
Multi-tasking skills in a demanding fast-paced environment.
Superior time-management skills.
Superior written and oral communications skill sets.
Willingness and ability to travel

Education and/or experience

Higher level of technical education (e.g., Science degree, Diploma, or Alternative technical bachelor’s degree or non-technical degree, diploma or Certificate).
Requires 5+ years of experience in Quality, Manufacturing, Engineering or related field; cross-industry experience a plus (e.g., automotive, aerospace, combination products, pharmaceuticals).
Experience auditing manufacturing facilities relevant to the defined supplier commodity portfolio.
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

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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Address

Explore this location Triq San Giljan
San Gwann
SGN3000
Malta Explore This Location

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.”

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.”

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.”

Join Our Talent Community

We're grateful for your interest in a career with Baxter, and would like to get to know you. Joining our Talent Community is a great way to stay connected, learn more about Baxter, and help our recruiters find you if there's an opportunity that aligns with your background, skills and interests.

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Associate - EMEA Supplier Quality

Overview

Success Profile

Associate - EMEA Supplier Quality

Address

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Hear from Our Employees

Meet Christelle, Senior Quality Manager in Malta

Meet Lorena, Senior QA Associate in London, UK

Meet Gary, Quality Research Manager in Singapore

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Join Our Talent Community