Senior Associate - EMEA Supplier Quality

<p><b>This is where </b>your work makes a difference.</p><p></p><p>At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.</p><p></p><p>Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.</p><p></p><p>Here, you will find more than just a job—you will find purpose and pride. </p><p></p><p></p><p><b>Summary</b></p><p>Independently handles Supplier Quality System activities for assigned suppliers. Responsible for activities such as execution of quality assessments and audits, negotiation and implementation of Quality Agreements, monitoring and reporting of metrics. Lead Quality and Compliance related issues between suppliers and Baxter.</p><p></p><p><b>Essential Duties and Responsibilities:</b></p><ul><li><p>Set Quality system requirements to suppliers.</p></li><li><p>Perform Qualification of suppliers of Raw Materials, Medical Devices, Pharmaceutical, Services, Finished Products and oversee their placement on the Approved Entity List (AEL), including ensuring the creation and maintenance of supporting evidence.</p></li><li><p>Conduct and oversee supplier audits, qualification and requalification; Collect, trend and report supplier quality metrics, also management of global audits performed by third party service.</p></li><li><p>Oversee and negotiate Quality Agreements between suppliers and Baxter.</p></li><li><p>Improve/develop quality systems at selected suppliers for QMS and compliance improvement.</p></li><li><p>Evaluate and improve the effectiveness of purchasing controls and supplier quality processes and procedures.</p></li><li><p>Assist in preparing for and defending Purchasing Controls in inspections by external agencies or internal Baxter audits of Purchasing Controls processes; Handle and oversee audits CAPA, including root cause identification, and effective and timely closure.</p></li><li><p>Develop and/or deliver training to internal teams and suppliers.</p></li><li><p>Reviewing and assessing suppliers and addressing any blocking issues that arise.</p></li><li><p>Support Manufacturing, Regulatory, Quality and Purchasing organization or all other Location of Use (LOU) organization for third party suppliers related activities, as applicable.</p></li><li><p>Support other projects as appropriate.</p></li><li><p>Willingness to travel up to 40% as necessary.</p></li></ul><p></p><p><b>Qualifications:</b></p><ul><li><p>Prior auditing experience; Lead auditor qualification is beneficial; Knowledge of pharmaceutical and/or medical device regulations,e.g., ISO 13485, ISO 9001, ISO 17025, FDA cGMP, MDD, Eudralex GMP, GAMP 5.</p></li><li><p>Experience in Product/process development and/or supplier quality improvement.</p></li><li><p>Understanding of Business Insight; knowledgeable in current and possible future policies, practices, trends, technology, and information affecting their industry, business and organization.</p></li><li><p>Collaboration and Teamwork: Strong communication, facilitation, coordination, and team skills, excellent time-management abilities, attention to details, and a passion for quality, outstanding written and oral communication skills.</p></li><li><p>Proficient English is mandatory!</p></li></ul><p></p><p><b>Education and/or Experience:</b></p><ul><li><p>Higher level of technical education (e.g., Science degree, Diploma, or Alternative technical bachelor’s degree or non-technical degree, diploma or Certificate).</p></li><li><p>Requires 5+ years of experience in Quality, Manufacturing, Engineering or related field, combination products, medical devices and pharmaceuticals. Experience with other commodities relevant to medical devices or pharmaceuticals will also be considered.</p></li><li><p>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.</p></li></ul><p></p><p><b>What do we offer?</b></p><ul><li><p>Fixed-term contract for 3 months and then for an indefinite period.</p></li><li><p>Competitive salary, annual bonuses, recognition award program.</p></li><li><p>Possibilities for development on a personal and professional level in one of the leading global MedTech companies.</p></li><li><p>Package of benefits including Private medical care (Lux Med), Life Insurance, Multisport card.</p></li><li><p>Bax4U - cafeteria/lunch cards (300 PLN).</p></li><li><p>PPE program with very attractive conditions available for each em