At a Glance
- Tasks: Support quality systems and ensure compliance in manufacturing processes.
- Company: Join a leading company committed to quality and innovation.
- Benefits: Competitive pay, inclusive environment, and growth opportunities.
- Other info: Collaborative culture with a focus on continuous improvement.
- Why this job: Make a real impact on product quality and safety in healthcare.
- Qualifications: Degree in science or engineering and 3 years in quality roles.
The predicted salary is between 35000 - 45000 £ per year.
We are searching for the best talent for Process Quality Engineer.
Purpose
Part of the Quality team reporting into the Quality Engineering Team Leader. This role provides Quality Engineering support to site manufacturing processes in Base Business by maintaining and developing the Quality System. This includes the procedures and records required for the development, validation and production of CMW products and processes in order to assure the ongoing quality of products and maintain compliance with ISO 9000, ISO13485, FDA QSRs and the Medical Devices Directive.
You Will Be Responsible For
- Under limited supervision, and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines, this position must perform monthly trending of non-conformances and generate data as is required for Dashboard reviews.
- Ensure all assigned quality actions are investigated, have causes identified and action plans completed to the agreed schedule, regardless of source.
- Lead investigations into product or process issues raised, identifying root cause and corrective action plans as required.
- Partner with Engineering team during the definition and introduction of new or improved processes, delivering all validation, calibration, risk management and documentation needs.
- Own Validation Master Plan and Quality validation review activities for site production processes.
- Support operations and engineering teams to ensure that Preventive and Corrective Maintenance activities are completed to schedule and work with operations partners on process improvement activities including Lean Manufacturing activities.
- Present business related issues or opportunities to next management level when the need arises.
Qualifications / Requirements
- A minimum of a degree in a scientific or engineering field.
- A minimum of 3 years of experience in a quality, technical, or manufacturing role within a regulated industry.
- Well-developed interpersonal and collaboration skills.
- Solid understanding of ISO 9001, ISO 13485, and FDA Quality System Regulations is preferred.
- Understanding of Good Manufacturing Practice (GMP).
- Previous exposure to quality systems, including ISO 13485 and FDA QSRs.
- In-depth knowledge of validation and change control processes.
- Knowledge of quality tools such as FMEA, root cause investigation, Lean, and Six Sigma methodologies.
- Strong computer literacy.
- Ability to apply structured problem-solving and make informed decisions.
- Ability to communicate effectively across multiple levels of the organization.
- Ability to build and maintain positive working relationships.
- Demonstrated understanding of AI concepts and frameworks, including responsible and ethical AI practices, with experience using effective prompt generation to improve efficiency and productivity.
Benefits
We are committed to creating an inclusive work environment where all employees can thrive. We offer competitive compensation and benefits, along with opportunities for learning, development, and career growth. We are an equal opportunity employer and provide reasonable accommodations throughout the recruitment process.
Preferred Skills
- Customer Centricity
- Data Savvy
- Document Management
- Execution Focus
- Good Automated Manufacturing Practice (GAMP)
- Issue Escalation
- Lean Supply Chain Management
- Process Control
- Process Improvements
- Quality Control Testing
- Quality Services
- Quality Standards
- Quality Systems Documentation
- Science, Technology, Engineering, and Math (STEM) Application
- Supervision
- Supply Planning
- Technologically Savvy
Quality Engineer employer: Johnson & Johnson MedTech
At Johnson & Johnson, we pride ourselves on being an exceptional employer, particularly for our Quality Engineer role in Blackpool. Our commitment to fostering an inclusive work environment is matched by our dedication to employee growth, offering competitive benefits and opportunities for professional development. Join us to be part of a collaborative culture that values innovation and quality, ensuring you can make a meaningful impact in the medical devices sector.
Contact Details:
Johnson & Johnson MedTech Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Quality Engineer
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their quality systems and be ready to discuss how your experience aligns with their needs. Show them you’re not just another candidate!
✨Tip Number 3
Practice your problem-solving skills! Be ready to tackle hypothetical scenarios related to quality engineering during interviews. Use examples from your past experiences to demonstrate your structured approach.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Quality Engineer
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Engineer role. Highlight your experience with ISO standards and any relevant quality tools you've used. We want to see how your skills match what we're looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality engineering and how your background makes you a great fit for our team. Keep it engaging and personal – we love a good story!
Showcase Your Problem-Solving Skills:In your application, don’t forget to mention specific examples of how you've tackled challenges in previous roles. We’re keen on seeing your structured problem-solving approach and how you’ve made informed decisions in the past.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re serious about joining our awesome team at StudySmarter!
How to prepare for a job interview at Johnson & Johnson MedTech
✨Know Your Quality Standards
Make sure you brush up on ISO 9001, ISO 13485, and FDA QSRs before the interview. Being able to discuss these standards confidently will show that you understand the regulatory landscape and can navigate it effectively.
✨Showcase Your Problem-Solving Skills
Prepare examples of how you've tackled quality issues in the past. Use the STAR method (Situation, Task, Action, Result) to structure your responses, highlighting your structured problem-solving approach and decision-making abilities.
✨Familiarise Yourself with Lean Methodologies
Since the role involves process improvement activities, be ready to discuss your experience with Lean, Six Sigma, or other quality tools. Share specific instances where you've applied these methodologies to enhance efficiency or resolve issues.
✨Build Rapport with Your Interviewers
Quality Engineering is all about collaboration. During the interview, focus on building a connection with your interviewers. Ask insightful questions about their team dynamics and how they approach quality challenges to demonstrate your interpersonal skills.
