Quality Engineer - ISO 9001/13485 & Process Improvement

healthcare; Wrocław; On-site; PLN 110,000 - 170,000; Full time

Job summary

Solventum in Wrocław is seeking a Quality Engineer (m/f/x) to audit, improve and document quality processes across the organization. You will participate in new product and process implementations, validate test methods, and ensure supplier and product quality meets ISO standards, with a focus on continuous improvement.

Onsite 4 days per week at the Medical Surgical Division, the replacement position is a 2-year contract with possible extension.

Qualifications

• Higher education, preferably technical.
• Min. 3 years of experience in an independent position in the quality assurance department.
• Advanced knowledge of English, both spoken and written.

Responsibilities

• Performing the function of an internal and external auditor.
• Identification of areas for improvement, implementation of corrective and preventive actions and verification of their effectiveness.
• Conducting complaint processes.
• Development, implementation and updating of quality documentation.
• Continuous improvement of the Quality Management System to ensure compliance with ISO 9001, ISO13485 requirements.
• Participation in new product and process implementation projects.
• Validation of test methods.
• Cooperation with other departments to continuously develop and improve the functioning of the factory.
• Cooperation in the international arena.
• Ensuring the highest quality of raw materials, semi-finished products and finished products.
• Conducting training for employees in the scope of quality assurance requirements and methods of meeting them.
• Representing the area during external audits.

Skills

Advanced English

MS Office

MiniTab

Strong communication

Analytical thinking

Education

Higher education, preferably technical

Tools

SAP

Quality tools

Job description

Solventum in Wrocław is seeking a Quality Engineer (m/f/x) to audit, improve and document quality processes across the organization. You will participate in new product and process implementations, validate test methods, and ensure supplier and product quality meets ISO standards, with a focus on continuous improvement.

Onsite 4 days per week at the Medical Surgical Division, the replacement position is a 2-year contract with possible extension.