Senior Design Quality Engineer - #1784504

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function

Quality

Job Sub Function

R&D/Scientific Quality

Job Category

Professional

All Job Posting Locations:

Leeds, West Yorkshire, United Kingdom

Job Description

JOB SUMMARY

Leading product development activities from a Technical Quality perspective, by preparing appropriate Risk Management plans, supporting Design Control from concept to launch and leading all aspects of process verification & validation with internal manufacturing sites and/or external suppliers.

Driving the creation of a Risk Management Plan from the product concept phase and maintaining this plan to all phases. Input into risk assessment activities is needed, which includes developing and employing Hazard analysis and evaluation and other Quality Assurance risk analysis techniques to minimize potential risks during the development and implementation stages. Supporting post-market surveillance processes to continue the full risk lifecycle by reviewing field inquiry reports, and assisting or leading product Health Hazard Evaluations.

Effective problem analysis and complaint investigations (CAPA) are key responsibilities, alongside defining appropriate corrective actions.

Lead Design Transfer by development of efficient process Verification and Validation Strategies in collaboration with all partners throughout the product development cycle is important. Additionally, the position requires facilitating the transfer of Design History Files as needed, ensuring that transfers are accurately integrated into the Quality System.

Collaborating closely with Research and Development is vital to ensure that Critical To Quality (CTQ) specifications are agreed upon and detailed for all New Product Developments (NPD). Finally, leading Design for Inspection activities for all NPD is required to ensure the adoption of the newest technology to minimize human factors.

Supporting audits and ensuring compliance to meet regulatory requirements.

Experience And Education

• A bachelor's degree or equivalent experience or qualification mechanical or industrial engineering.
• Experience in maintenance of Quality Systems.
• Proven expertise in a quality role within a regulated industry.
• A proven record of successfully introducing following products through design control in the Medical Device Industry, along with confirmed knowledge and proficiency in product verification and process validations.
• In-depth understanding of FDA and MDD Good Manufacturing Practice (GMP) requirements related to medical devices.
• Meaningful experience and training in Mechanical Engineering processes.
• Proficiency with validation techniques, including risk assessment, validation planning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), change control, and process verification.
• Comprehensive knowledge and experience in internal audit administration, Corrective and Preventive Actions (CAPA), and operational/executive management reviews.
  
  

Location & travel requirements

• Primary location is Leeds UK.
• 20% travel for domestic, international, or both.