Associate Supplier Quality, EMEA

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.

Associate Supplier Quality, EMEA

Role Summary:

• Independently manage Supplier Quality Assurance and Maintenance activities for assigned suppliers
• Supplier quality assessment and follow-up of supplier failures and low performers
• Lead activities such as execution of quality assessments/audits, negotiation and implementation of Quality Agreements, and monitoring and reporting of metrics.
• Manage quality and compliance-related issues between suppliers and Baxter. Perform Supplier audits.

Essential Duties and Responsibilities:

• Set Quality system requirements to 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:

• Experience in Supplier Quality Management.
• Strong quality orientation required.
• 5+ years’ experience in Quality, Supplier Quality, Manufacturing, Engineering or related field
• Knowledge of pharmaceutical and/or medical device regulations, e.g., ISO 13485, ISO 9001, FDA cGMP, international cGMP, MDD, MDR, Eudralex
• Auditing skillsets, up to and including certified SQ lead auditor training; Quality Management System auditing
• Collaboration and Teamwork: effective communicator at all levels, both internally and externally; excellent written, oral, and interpersonal communication and presentation skills
• Project management skills managing multiple issues of moderate to high complexity relatively independently
• Ability to manage the Quality relationship with assigned key suppliers
• Superior time-management skills
• Multi-tasking skills in a demanding, fast-paced environment.

What we offer:

• The probation period is 3 months and then for an indefinite period.
• Competitive salary, annual bonuses, recognition award program.
• Corporate culture is based on our values: collaboration, speed, courage, and simplicity.
• Possibilities for development on a personal and professional level in one of the leading global MedTech companies.
• Package of benefits including Private medical care (Lux Med), Life Insurance, and a Multisport card.
• Bax4U - cafeteria/lunch cards (300 PLN monthly).
• PPE program with very attractive conditions available for each employee after 3 months.
• Fully covered language courses (English or other languages according to business needs).
• Co-financing of holidays and an additional 2 days off from work annually and an extra day off for your birthday!
• Employee Stock Purchase Plan.
• Phenomenal Warsaw office location - Powiśle!

Baxter is committed to supporting the need for flexibility in the workplace. We do so through our flexible workplace policy, which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change.

We are an equal opportunity employer and value diversity at our company. We do not discriminate based on race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request an accommodation.

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.