Quality Engineer - 24 months contract

• Supports design transfer from R&D to Manufacturing, including risk management activities, process validation, and manufacturing readiness.
• Acts as a quality partner within cross functional project teams to ensure quality and regulatory readiness prior to product launch or product transfer.
• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborate with development team on NPI, definition of strategies for validation and qualification of processes and equipment, support characterization of processes through structural approach and usage of Design for Reliability and Manufacturability.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
• Provides quality support to pre market projects, including product development, process development, industrialization, and product transfer activities.
• Ensure quality deliverables are defined and executed throughout design and process development phases in compliance with Design Control requirements.

• Master’s degree or equivalent, with at least 2 years of experience.
• English min B2.
• Strong working knowledge of Quality Management Systems (QMS) compliant with:

• Solid understanding of software and/or hardware validation (as applicable).
• Ability to work cross-functionally with R&D, Manufacturing, Regulatory Affairs, and Supplier Quality.
• Strong documentation, analytical, and problem-solving skills.
• Experience supporting pre market quality activities within product and/or process development projects.
• Working knowledge of design transfer and industrialization activities in a regulated medical device environment.
• Experience contributing to pre market documentation such as Design History File (DHF), risk management files, and validation documentation.

Medtronic