What will you do:

• Regulatory Compliance & Collaboration: Collaborate with cross-functional teams to ensure project compliance with regulatory standards and optimize performance.

• Specification & Procurement Support: Develop User Requirements Specifications and assist in device procurement, development, and commissioning.

• Validation Management: Lead validation efforts by creating and managing FAT, SAT, IQ, OQ, OQ-P, EQ, and PQ processes in the Val-G database, ensuring thorough documentation.

• Process Consistency & System Evaluation: Ensure manufacturing processes yield consistent, reproducible results; evaluate systems, conduct tests, and document findings to meet company and regulatory standards.

• Protocol & Validation Leadership: Manage protocol approval sessions with Validation Representatives, support the Product Transfer Process team, and serve as the validation expert for ISO 13485 compliance.

• Change Management & Documentation: Initiate and upload PFD PFMEA, PCP, DMR, DHR, PRT, ECR, and ECN documents to onePLM, ensuring timely release and updates.

• Training & Coordination: Develop and execute training plans for Capability, MSA, and other processes, coordinating with Process Engineers for timely document release and training plans in onePLM.

What do you need to be successful:

• Bachelor’s degree in Quality, Biochemistry, Mechanical, Chemical, Materials, or Automation Engineering.

• Hands-on experience with validation processes, including equipment qualification, performance qualification, and process qualification.

• Familiarity with FDA, ISO, GMP standards, and quality assurance methodologies.

• Strong problem-solving abilities to troubleshoot and optimize validation processes.

• High level of precision in documenting validation processes and results, with a strong documentation bias to manage the entire validation process.

• Enthusiasm for collaborative work with excellent verbal and listening skills to effectively share information within the team.

• Proficient in Polish and English

• “Right First Time" Mentality: Commitment to quality and accuracy, understanding that your work has a direct impact on patient health.

• Additional Skills: Experience with Six Sigma, Cp, Cpk, and MSA practices is an advantage.