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For Companies At a Glance
- Tasks: Manage CAPA activities, conduct audits, and improve QMS documentation.
- Company: Join a leading tech development and manufacturing business focused on quality.
- Benefits: Enjoy hybrid work, competitive salary, bonuses, and extensive perks.
- Why this job: Make a real impact on product quality and compliance in a dynamic environment.
- Qualifications: Experience with QMS in medical devices or pharmaceuticals is essential.
- Other info: Salary starts at £38,000 with a 10% bonus.
The predicted salary is between 22800 - 42000 £ per year.
Job Description
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.
Salary: £38,000 + 10% Bonus + Benefits
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Quality Engineer employer: ZipRecruiter
Contact Detail:
ZipRecruiter Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Engineer
✨Tip Number 1
Familiarize yourself with ISO 13485, MDD, and FDA regulations. Having a solid understanding of these standards will not only help you in interviews but also demonstrate your commitment to quality management systems.
✨Tip Number 2
Prepare specific examples from your previous experience managing QMS systems, especially in medical device or pharmaceutical settings. Highlight your involvement in CAPA activities and how you contributed to compliance and quality improvements.
✨Tip Number 3
Practice discussing your experience with internal and external audits. Be ready to explain how you prepared for these audits and the outcomes, as this will showcase your ability to manage quality processes effectively.
✨Tip Number 4
Network with professionals in the quality engineering field, especially those who have experience in the medical device industry. Engaging with others can provide insights and potentially lead to referrals that could help you land the job.
We think you need these skills to ace Quality Engineer
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Quality Engineer position. Highlight key responsibilities and required skills, such as managing CAPA activities and knowledge of ISO 13485.
Tailor Your CV: Customize your CV to reflect your experience with QMS systems, particularly in medical device or pharmaceutical settings. Emphasize relevant achievements and specific examples that demonstrate your expertise in CAPA, audits, and regulatory compliance.
Craft a Compelling Cover Letter: Write a cover letter that connects your background to the job requirements. Discuss your experience with internal and external audits, and how you can contribute to improving QMS documentation and processes.
Proofread Your Application: Before submitting, carefully proofread your application materials. Check for any spelling or grammatical errors, and ensure that all information is clear and professional. A polished application reflects your attention to detail, which is crucial for a Quality Engineer.
How to prepare for a job interview at ZipRecruiter
✨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.
✨Understand Relevant Regulations
Familiarize yourself with ISO 13485, MDD, and FDA regulations before the interview. Being able to discuss these standards confidently will demonstrate your expertise and readiness for the role.
✨Prepare for Audit Scenarios
Since the role involves conducting and supporting audits, think of examples from your past where you performed internal audits or hosted external audits. Be ready to explain your approach and any challenges you faced.
✨Emphasize Team Collaboration
The position requires advising engineering, production, and design teams. Prepare to share experiences where you successfully collaborated with cross-functional teams to improve quality processes or documentation.
