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- Tasks: Manage CAPA activities, conduct audits, and improve quality documentation.
- Company: Join a leading tech development and manufacturing business focused on quality and compliance.
- Benefits: Enjoy hybrid work, competitive salary, 10% bonus, and extensive benefits.
- Why this job: Make a real impact on product quality while working in a dynamic environment.
- Qualifications: Experience with QMS in medical devices or pharmaceuticals; knowledge of ISO 13485 and FDA regulations.
- Other info: Ideal for those passionate about quality systems and regulatory standards.
The predicted salary is between 22800 - 42000 £ per year.
Opportunity for an experienced Quality Systems Engineer to join an established technology development and manufacturing business. As Quality Systems Engineer your activities will contribute to the overall business performance, compliance and quality of products. The business offers hybrid working, competitive salary, bonus and extensive benefits
What you’ll be doing:
• Manage CAPA activities and associated reporting
• Conduct and support internal and external audits
• Manage QMS and relevant quality documentation
• Advise engineering, production and design teams on relevant regulatory requirements and standards
• Provide internal guidance and training relating to QMS documentation and processes
• Develop new and improve existing QMS documentation and processes
What you will bring to the role:
• Previous experience managing QMS systems in a medical device or pharmaceutical setting including CAPA, NCRs, ECNs, ECRs etc
• Ideally detailed knowledge of ISO 13485, MDD and FDA regulations
• Experience performing internal audits and hosting external
Salary: £38,000 + 10% Bonus + Benefits
Quality Engineer employer: Linea Resourcing - STEM Recruiter
Contact Detail:
Linea Resourcing - STEM Recruiter Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Engineer
✨Tip Number 1
Familiarize yourself with the specific regulations and standards mentioned in the job description, such as ISO 13485 and FDA regulations. This knowledge will not only help you during the interview but also demonstrate your commitment to quality systems.
✨Tip Number 2
Prepare examples from your previous experience where you successfully managed CAPA activities or conducted audits. Being able to discuss real-life scenarios will showcase your expertise and problem-solving skills.
✨Tip Number 3
Network with professionals in the medical device or pharmaceutical industry. Engaging with others in your field can provide valuable insights and potentially lead to referrals for the Quality Engineer position.
✨Tip Number 4
Research the company’s products and their impact on the market. Understanding their business model and how quality systems contribute to their success will allow you to tailor your responses during the interview.
We think you need these skills to ace Quality Engineer
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly read the job description for the Quality Engineer position. Make sure you understand the key responsibilities and required qualifications, especially regarding QMS systems and regulatory standards.
Tailor Your CV: Customize your CV to highlight your relevant experience in managing QMS systems, particularly in medical device or pharmaceutical settings. Emphasize your familiarity with ISO 13485, MDD, and FDA regulations.
Craft a Compelling Cover Letter: Write a cover letter that connects your past experiences with the specific requirements of the role. Mention your experience with CAPA activities, internal audits, and how you can contribute to the company's quality performance.
Highlight Your Skills: In your application, make sure to showcase your skills in advising teams on regulatory requirements and your ability to develop and improve QMS documentation. This will demonstrate your value to the company.
How to prepare for a job interview at Linea Resourcing - STEM Recruiter
✨Showcase Your QMS Experience
Be prepared to discuss your previous experience managing Quality Management Systems, especially in medical device or pharmaceutical settings. Highlight specific examples of CAPA activities you've managed and how they contributed to compliance and quality.
✨Demonstrate Knowledge of Regulations
Familiarize yourself with ISO 13485, MDD, and FDA regulations. During the interview, confidently discuss how your knowledge of these standards has influenced your work and decision-making processes in past roles.
✨Prepare for Audit Scenarios
Expect questions related to internal and external audits. Prepare to share your experiences conducting audits, including challenges faced and how you ensured compliance. This will demonstrate your hands-on expertise in maintaining quality standards.
✨Emphasize Team Collaboration
Quality Engineers often work closely with engineering, production, and design teams. Be ready to provide examples of how you've advised these teams on regulatory requirements and how you facilitated training on QMS documentation and processes.
