Project Quality Engineer

Summary: The Project Quality Engineer will lead the quality assurance aspects of process improvements, new product introductions, and product transfers at DePuy Synthes in Leeds, UK. This role involves collaboration with cross-functional teams to ensure compliance with quality standards and timely project completion. The engineer will also be responsible for validation protocols, risk analysis, and problem-solving in a regulated medical device environment. A strong background in mechanical or industrial engineering and experience in quality roles within the medical device industry are essential for success in this position.

Key Responsibilities:

• Represent Quality in cross-functional teams to ensure project delivery with high quality and compliance.
• Compile and execute validation protocols for new products and processes.
• Re-validate processes due to engineering changes or upgrades.
• Utilize statistical analysis for validation activities and define inspection controls.
• Develop and apply DFMEA/PFMEA and other QA risk analysis techniques.
• Liaise with R&D to document Critical to Quality Characteristics for new products.
• Lead Design for Inspection activities for new product introductions.
• Ensure compliance with FDA QSR’s and ISO 13485/9001 requirements.
• Provide technical assistance for problem analysis and complaint investigations.
• Assist in problem-solving for new products and established processes.
• Review and approve product, gauge, tooling, and fixturing drawings.
• Maintain housekeeping and observe Health and Safety requirements.

Key Skills:

• Degree in mechanical or industrial engineering or similar qualification.
• Minimum 2 years of experience in a quality role within a regulated industry.
• Experience in new product development in the Medical Device Industry.
• Knowledge of product verification and process validations.
• Understanding of FDA and MDD GMP requirements for medical devices.
• Experience in Mechanical Engineering processes.
• Strong project management skills.
• Good communication and influencing skills.
• Ability to work flexibly as a team player.
• Culturally aware and politically sensitive.

Salary (Rate): undetermined

City: Leeds

Country: United Kingdom

Working Arrangements: undetermined

IR35 Status: inside IR35

Seniority Level: undetermined

Industry: IT