Informacje o stanowisku

Description

The Supplier Quality Engineer (SQE) is responsible for ensuring that external suppliers meet quality standards and regulatory requirements for the supply of materials, components, and services used in the production of medical devices. The SQE plays a crucial role in maintaining a reliable supply chain and ensuring the safety, efficacy, and quality of products.

Responsibilities

• Evaluate potential suppliers and conduct supplier assessments to ensure they meet quality and regulatory requirements.
• Develop and maintain supplier quality agreements outlining quality standards, responsibilities, and expectations.
• Lead parts qualification activities, including material qualification, and validation of incoming components to ensure they meet quality requirements.
• Review and approve supplier documentation, including quality plans, process validation, control plans, risk analysis, certificates of analysis, and inspection records.
• Perform supplier audits and assessments to verify compliance with quality management systems, regulatory requirements, and industry standards.
• Monitor supplier performance through key performance indicators (KPIs) and quality metrics, and address any deviations or non-conformities.
• Collaborate with suppliers to implement corrective and preventive actions (CAPA) to address quality issues and improve supplier performance.
• Provide technical support and guidance to suppliers on quality requirements, process improvements, and regulatory compliance.
• Participate in new product development projects to assess supplier capabilities, qualify new suppliers, and ensure smooth integration of new materials and components into production processes.

Qualifications:

• Bachelor’s degree in engineering, quality management, or related field.
• Previous experience in supplier quality management, quality assurance, or related field within the medical device industry.
• Strong understanding of quality management systems, regulatory requirements (e.g., ISO 13485, FDA regulations), and industry standards (e.g., ISO 14971, ISO 9001).
• Experience conducting supplier audits, assessments, and evaluations.
• Excellent communication, negotiation, and interpersonal skills.
• Ability to analyze data, identify trends, and drive continuous improvement initiatives.
• Detail-oriented with a commitment to accuracy and compliance.

We offer:

• Full-time job contract.
• Opportunity to work in an international environment.
• A number of benefits (private medical care, sports card, flexible working time, Home Office, co-financing of holidays, co-financing for English language classes, fruit and snacks).
• Great atmosphere in the office and interesting challenges.
• Opportunity to grow with the organization and build a successful career path.
• Internal and external training.

Poznań - Oferty pracy w okolicznych lokalizacjach