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- Tasks: Lead product development with a focus on quality, risk management, and compliance.
- Company: Join Johnson & Johnson, a leader in healthcare innovation dedicated to improving global health.
- Benefits: Enjoy competitive pay, flexible working options, and opportunities for professional growth.
- Why this job: Make a real impact in healthcare while collaborating with cutting-edge technology and passionate teams.
- Qualifications: Bachelor's degree in engineering or equivalent, with experience in quality roles in regulated industries.
- Other info: Position based in Leeds with 20% travel required.
The predicted salary is between 43200 - 72000 £ per year.
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 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.
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Senior Design Quality Engineer employer: Johnson and Johnson
Contact Detail:
Johnson and Johnson Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Design Quality Engineer
✨Tip Number 1
Familiarise yourself with the latest FDA and MDD Good Manufacturing Practice (GMP) requirements. Understanding these regulations will not only help you in interviews but also demonstrate your commitment to quality in the medical device industry.
✨Tip Number 2
Network with professionals in the medical device sector, especially those who have experience in quality roles. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in design quality engineering.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully led product development activities and managed risk assessments in previous roles. Having concrete stories ready will showcase your expertise and problem-solving skills during the interview.
✨Tip Number 4
Stay updated on the latest technologies and methodologies in design for inspection and validation techniques. Being knowledgeable about innovative practices will set you apart as a candidate who is forward-thinking and ready to contribute to the company's goals.
We think you need these skills to ace Senior Design Quality Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality engineering, particularly in the medical device industry. Emphasise your expertise in risk management, design control, and compliance with FDA and MDD GMP requirements.
Craft a Compelling Cover Letter: Write a cover letter that connects your background to the specific responsibilities of the Senior Design Quality Engineer role. Mention your experience with product verification and validation, and how you can contribute to Johnson & Johnson's mission of healthcare innovation.
Showcase Relevant Skills: In your application, clearly outline your skills in CAPA, internal audits, and validation techniques. Provide examples of how you've successfully introduced products through design control and your understanding of mechanical engineering processes.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors or inconsistencies. A polished application reflects your attention to detail, which is crucial for a role in quality engineering.
How to prepare for a job interview at Johnson and Johnson
✨Understand the Role Thoroughly
Before your interview, make sure you have a solid grasp of the Senior Design Quality Engineer role. Familiarise yourself with the key responsibilities such as risk management, design control, and process validation. This will help you articulate how your experience aligns with their needs.
✨Showcase Your Technical Expertise
Be prepared to discuss your technical skills in detail, especially regarding FDA and MDD GMP requirements. Highlight specific projects where you've successfully introduced products through design control in the Medical Device Industry, as this will demonstrate your relevant experience.
✨Prepare for Problem-Solving Questions
Expect questions that assess your problem analysis and complaint investigation skills. Prepare examples of past challenges you've faced in quality roles and how you implemented corrective actions (CAPA) to resolve them. This will showcase your critical thinking and analytical abilities.
✨Emphasise Collaboration Skills
Since the role involves close collaboration with R&D and other partners, be ready to discuss your teamwork experiences. Share examples of how you've worked effectively with cross-functional teams to ensure Critical To Quality (CTQ) specifications are met during new product developments.
