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For Companies At a Glance
- Tasks: Lead quality assurance for medical devices, ensuring compliance and excellence in processes.
- Company: Join a rapidly growing company specializing in innovative medical technology.
- Benefits: Enjoy a dynamic work environment with opportunities for professional growth and impact.
- Why this job: Make a real difference in healthcare while working with cutting-edge technology and a passionate team.
- Qualifications: 5+ years in Quality Engineering with strong knowledge of ISO standards and regulatory compliance.
- Other info: Ideal for those looking to drive innovation in the medical field.
The predicted salary is between 43200 - 72000 £ per year.
Job Description
Senior Quality Engineer – Medical Devices & IVDs
Are you an experienced Senior Quality Engineer looking for a career-defining opportunity in the medical technology space? We’re hiring!
Join an innovative and rapidly growing company that specializes in medical devices . This is your chance to play a key role in ensuring compliance with ISO 13485 / MDSAP standards while driving excellence across design, development, and manufacturing processes.
Location: Inverness, Highlands
Industry: Medical Devices | IVD | Quality Engineering
What You’ll Be Doing:
Develop and maintain technical documentation to meet regulatory & quality standards.
Lead the transition to a full eQMS system and provide training.
Manage design control processes for Class II/III medical devices & Class C IVDs .
Support regulatory submissions and market authorization applications.
Conduct internal audits, risk management, and CAPA investigations .
Provide quality oversight to suppliers & contractors .
Organize and lead Quality Management Review Board meetings.
What We’re Looking For:
5+ years of experience in Quality Engineering within Medical Devices or IVDs.
Strong knowledge of ISO 13485, MDSAP, and ISO 14971 .
Expertise in design controls, risk management, and regulatory compliance .
Proven experience working within an FDA-compliant QMS .
Excellent documentation skills and ability to communicate complex regulations.
Bonus Points For:
Experience in medical device (MD) or IVD product development .
Lean/Six Sigma certification.
ISO 13485:2016 Internal Auditor certification.
This is a fantastic opportunity to drive real impact in a company pushing the boundaries of medical innovation. If this sounds like you—or someone in your network—let’s connect!
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Staff/Senior Quality Engineer employer: ZipRecruiter
Contact Detail:
ZipRecruiter Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Staff/Senior Quality Engineer
✨Tip Number 1
Make sure to highlight your experience with ISO 13485 and MDSAP standards during any networking opportunities. Connect with professionals in the medical device industry on platforms like LinkedIn to discuss your expertise and learn about potential openings.
✨Tip Number 2
Consider joining relevant professional groups or forums focused on quality engineering in medical devices. Engaging in discussions can help you stay updated on industry trends and may lead to job referrals.
✨Tip Number 3
Attend industry conferences or webinars related to medical devices and quality engineering. These events are great for networking and can provide insights into what companies like us are looking for in candidates.
✨Tip Number 4
If you have Lean/Six Sigma certification, be sure to mention it in conversations with industry contacts. This can set you apart from other candidates and show your commitment to quality improvement.
We think you need these skills to ace Staff/Senior Quality Engineer
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Senior Quality Engineer position. Understand the key responsibilities and required qualifications, especially regarding ISO 13485 and MDSAP standards.
Tailor Your CV: Customize your CV to highlight your relevant experience in Quality Engineering, particularly in medical devices or IVDs. Emphasize your knowledge of regulatory compliance and any specific projects that align with the job requirements.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for medical technology and your expertise in quality engineering. Mention specific experiences that demonstrate your ability to manage design control processes and conduct internal audits.
Highlight Certifications: If you have certifications such as Lean/Six Sigma or ISO 13485:2016 Internal Auditor, make sure to include them prominently in your application. These credentials can set you apart from other candidates.
How to prepare for a job interview at ZipRecruiter
✨Showcase Your Experience
Be prepared to discuss your 5+ years of experience in Quality Engineering, specifically within Medical Devices or IVDs. Highlight specific projects where you ensured compliance with ISO 13485 and MDSAP standards.
✨Demonstrate Technical Knowledge
Familiarize yourself with the technical documentation requirements and be ready to explain how you've developed and maintained such documents in previous roles. This will show your understanding of regulatory and quality standards.
✨Discuss Leadership in Quality Management
Prepare examples of how you've led design control processes or managed internal audits. Discuss your experience organizing Quality Management Review Board meetings and how you drove improvements in quality oversight.
✨Communicate Complex Regulations Clearly
Practice explaining complex regulations in simple terms. This is crucial as you'll need to communicate effectively with various stakeholders, so demonstrating your ability to simplify intricate concepts will set you apart.
