What will you do?

• Collaborative Compliance: Work closely with cross-functional teams to ensure all aspects of product transfer are compliant with regulatory requirements and optimized for performance.
• Specification and Procurement Support: Develop User Requirements Specifications and support device procurement, development, and commissioning stages.
• Validation Expertise: Create and manage FAT, SAT, IQ, OQ, OQ-P, EQ, and PQ entities within the Val-G database, ensuring all validation processes are meticulously documented.
• Process Consistency: Ensure that manufacturing processes lead to consistent and reproducible results, meeting both company and regulatory standards.
• System Evaluation: Evaluate systems and processes used in product manufacturing, running tests, analyzing data, and documenting results to ensure they meet Stryker’s rigorous standards.
• Protocol Management: Initiate and maintain protocol approval sessions with Validation Representatives, supporting the Product Transfer Process engineering team in MSA and Capability study protocols.
• Validation Leadership: Act as the Subject Matter Expert in equipment and process validation, representing Product Transfer Engineering in ISO 13485 compliance matters.

What do you need?

• Educational Background: Bachelor’s degree in Quality, Biochemistry, Mechanical, Chemical, Materials, or Automation Engineering.
• Practical Experience: Hands-on experience with validation processes, including equipment qualification, performance qualification, and process qualification.
• Regulatory Knowledge: Familiarity with FDA, ISO, GMP standards, and quality assurance methodologies.
• Analytical Skills: Strong problem-solving abilities to troubleshoot and optimize validation processes.
• Technical Proficiency: Good computer skills and a structured approach to work, ensuring accuracy in documentation and communication.
• "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.
• Language Skills: Proficient in Polish and English.