At a Glance
- Tasks: Join our Quality team to ensure top-notch standards in medical device manufacturing.
- Company: DePuy Synthes is a leader in innovative medical technologies, based in Blackpool.
- Benefits: Enjoy a dynamic work environment with opportunities for professional growth and development.
- Why this job: Make a real impact in healthcare while working with cutting-edge technology and a passionate team.
- Qualifications: Degree in a scientific field and 3 years of experience in quality or manufacturing roles required.
- Other info: We value diversity and are committed to equal opportunity for all applicants.
The predicted salary is between 36000 - 60000 £ per year.
Are you passionate about quality engineering and keen to work in the dynamic medical device sector? DePuy Synthes, a leader in the development of innovative medical technologies, is looking for an experienced Quality Engineer to join our team in Blackpool. If you thrive in a fast-paced, high-impact environment and are dedicated to ensuring the highest quality standards, this role is for you!
What You’ll Do:
As an Engineer in Quality Engineering, you will be part of a committed Quality team, collaborating with the Quality Engineering Team Leader. In this crucial role, you will ensure the ongoing quality and compliance of our manufacturing processes in Base Business. Your work will focus on maintaining and improving the Quality System to meet key regulatory standards including ISO 9000, ISO 13485, FDA QSRs, and the Medical Devices Directive.
Your key responsibilities will include:
- Monthly Trending & Dashboard Reviews: Track and analyze Non-Conformance (NC) data for production processes and generate insights for dashboard reviews.
- Root Cause Analysis & Action Plans: Investigate issues in products or processes, identify root causes, and develop corrective actions to ensure product quality.
- Collaborate with Engineering: Partner with the Engineering team to define, introduce, and optimize new or improved manufacturing processes.
- Validation Master Plan Ownership: Take ownership of the Validation Master Plan and coordinate quality validation reviews.
- Preventive & Corrective Maintenance: Support operations to ensure that maintenance activities are completed to schedule.
- Process Improvement & Lean Manufacturing: Work with teams to ensure compliance in continuous improvement activities, driving Lean Manufacturing initiatives.
- Regulatory Compliance: Ensure consistency to all relevant regulations governing business and quality operations.
What We’re Looking For:
To excel in this role, you will need strong technical expertise and a proven understanding of quality systems and regulatory requirements in a medical device environment.
Qualifications
- Education: A minimum of a degree in a scientific field.
- Experience: At least 3 years in a quality, technical, or manufacturing role within a regulated industry.
- Knowledge:
- In-depth knowledge of Good Manufacturing Practices (GMP).
- Familiarity with ISO 13485, FDA QSRs, and validation processes.
- Proficient with Quality Toolbox techniques such as FMEA, root cause investigations, Lean, and Six Sigma.
- Strong analytical and problem-solving skills.
- Excellent interpersonal skills, with the ability to engage optimally across all levels of the organization.
Quality Engineer employer: Johnson & Johnson
Contact Detail:
Johnson & Johnson Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Engineer
✨Tip Number 1
Familiarise yourself with the specific quality standards mentioned in the job description, such as ISO 9000 and ISO 13485. Understanding these regulations will not only help you during interviews but also demonstrate your commitment to quality engineering.
✨Tip Number 2
Network with professionals in the medical device sector, especially those who work at DePuy Synthes or similar companies. Engaging with industry peers can provide valuable insights and potentially lead to referrals that could enhance your application.
✨Tip Number 3
Prepare to discuss your experience with Quality Toolbox techniques like FMEA and root cause analysis. Be ready to share specific examples of how you've applied these methods in past roles to improve product quality and compliance.
✨Tip Number 4
Research DePuy Synthes and their recent projects or innovations in the medical device field. Showing that you are informed about the company’s work can set you apart and demonstrate your genuine interest in joining their team.
We think you need these skills to ace 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 sector. Emphasise your familiarity with ISO 13485 and FDA QSRs, as well as any specific projects that demonstrate your problem-solving skills.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality engineering and your understanding of regulatory compliance. Mention specific examples of how you've contributed to quality improvements in previous roles, especially in a regulated environment.
Highlight Relevant Skills: In your application, clearly outline your technical expertise and knowledge of Good Manufacturing Practices (GMP). Include any certifications or training related to Lean Manufacturing or Six Sigma that you possess.
Showcase Analytical Abilities: Demonstrate your analytical and problem-solving skills by providing examples of past experiences where you successfully conducted root cause analysis or implemented corrective actions. This will show your capability to handle the responsibilities outlined in the job description.
How to prepare for a job interview at Johnson & Johnson
✨Know Your Quality Standards
Familiarise yourself with key quality standards such as ISO 9000, ISO 13485, and FDA QSRs. Be prepared to discuss how these standards apply to your previous work and how you can ensure compliance in the role.
✨Demonstrate Problem-Solving Skills
Prepare examples of past experiences where you've successfully conducted root cause analysis and implemented corrective actions. Highlight your analytical skills and how they contributed to improving product quality.
✨Showcase Collaboration Experience
Emphasise your ability to work with cross-functional teams, especially with engineering. Share specific instances where your collaboration led to successful process improvements or quality enhancements.
✨Be Ready for Technical Questions
Expect technical questions related to Good Manufacturing Practices (GMP) and quality toolbox techniques like FMEA and Lean. Brush up on these topics to confidently demonstrate your expertise during the interview.