At a Glance
- Tasks: Support quality engineering in manufacturing processes and maintain compliance with industry standards.
- Company: Join Johnson & Johnson, a leader in healthcare innovation.
- Benefits: Competitive pay, inclusive culture, and opportunities for personal and professional growth.
- Other info: Collaborative environment with a focus on innovation and career advancement.
- Why this job: Make a real impact on health solutions while working with cutting-edge technology.
- Qualifications: Degree in science or engineering and experience in quality within regulated industries.
The predicted salary is between 35000 - 45000 € per year.
About Johnson & Johnson
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.
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.
Key Responsibilities
- 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 actions plans completed to the agreed schedule.
- 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.
- Work with operations partners on process improvement activities including Lean Manufacturing activities.
- Present business related issues or opportunities to next management level where 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.
Equal Opportunity
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.
Quality Engineer employer: Johnson & Johnson
At Johnson & Johnson, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration in the heart of Blackpool. Our commitment to employee growth is evident through comprehensive training programmes and career advancement opportunities, ensuring that every team member can thrive while contributing to groundbreaking healthcare solutions. With competitive compensation and a focus on inclusivity, we empower our employees to make a meaningful impact on health for humanity.
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 seen. 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 in quality systems, ISO standards, and any relevant technical skills. We want to see how your background aligns with 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 you can contribute to our mission at Johnson & Johnson. 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 value structured problem-solving, so share those experiences that demonstrate your analytical skills and decision-making abilities.
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, you’ll find all the details you need about the role and our company culture there!
How to prepare for a job interview at Johnson & Johnson
✨Know Your Quality Standards
Familiarise yourself with ISO 9001, ISO 13485, and FDA QSRs. Be ready to discuss how these standards apply to the role and share examples of how you've implemented them in past positions.
✨Showcase Your Problem-Solving Skills
Prepare to talk about specific instances where you've identified root causes and implemented corrective actions. Use structured problem-solving techniques like FMEA or Lean methodologies to demonstrate your approach.
✨Engage with the Engineering Team
Highlight your experience collaborating with engineering teams on process improvements. Discuss any successful projects where you partnered to enhance quality systems or validation processes.
✨Communicate Effectively
Practice articulating complex ideas clearly and concisely. Be prepared to present business-related issues or opportunities, showcasing your ability to communicate across various levels of an organisation.
