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- Tasks: Manage CAPA activities, conduct audits, and improve QMS documentation.
- Company: Join a leading tech development and manufacturing business focused on quality and compliance.
- Benefits: Enjoy hybrid working, 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 required.
- Other info: Perfect for those looking to grow their career in a supportive and innovative company.
The predicted salary is between 38000 - 53200 £ 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 audits • Excellent report writing and communication skills Salary: £38,000 + 10% Bonus + Hybrid + Benefits
Quality System 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 System Engineer
✨Tip Number 1
Familiarize yourself with ISO 13485 and FDA regulations. Understanding these standards will not only help you in interviews but also demonstrate your commitment to quality management systems.
✨Tip Number 2
Prepare examples from your previous experience where you've successfully managed CAPA activities or conducted audits. Being able to discuss specific situations will showcase your expertise and problem-solving skills.
✨Tip Number 3
Network with professionals in the medical device and pharmaceutical industries. Engaging with others in your field can provide valuable insights and potentially lead to referrals for the Quality Systems Engineer position.
✨Tip Number 4
Stay updated on the latest trends and changes in quality management systems. Showing that you're proactive about continuous learning can set you apart from other candidates.
We think you need these skills to ace Quality System Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience with Quality Management Systems (QMS) in medical devices or pharmaceuticals. Emphasize your familiarity with CAPA, NCRs, and relevant regulations like ISO 13485.
Craft a Strong Cover Letter: In your cover letter, explain why you are passionate about quality systems engineering. Mention specific examples of how you've managed QMS documentation and processes in previous roles.
Highlight Relevant Skills: Clearly outline your skills related to internal and external audits, report writing, and communication. These are crucial for the role and should be evident in both your CV and cover letter.
Proofread Your Application: Before submitting, carefully proofread your application materials. Ensure there are no typos or grammatical errors, as attention to detail is vital in quality systems engineering.
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 overcame them. This will demonstrate your problem-solving skills and attention to detail.
✨Communicate Effectively
Since excellent report writing and communication skills are essential for this role, practice articulating your thoughts clearly and concisely. Consider preparing a brief presentation on a relevant topic to showcase your ability to convey complex information effectively.
