Associate Supplier Quality, EMEA

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Juntos creamos un lugar donde somos felices, exitosos y nos inspiramos mutuamente. Aquí es donde puedes hacer tu mejor trabajo.

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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 fo