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- Tasks: Join our team as a Design Quality Engineer, ensuring top-notch quality in medical device design projects.
- Company: Work with a leading Medical Device Manufacturer committed to innovation and excellence.
- Benefits: Enjoy a dynamic work environment with opportunities for growth and development.
- Why this job: Make a real impact on healthcare by ensuring compliance and quality in life-saving products.
- Qualifications: Bachelor’s degree in Science or Engineering and 2+ years in a regulated environment required.
- Other info: Ideal for those passionate about quality and eager to collaborate across teams.
The predicted salary is between 36000 - 60000 £ per year.
Job Description
Our client, a leading Medical Device Manufacturer, is looking to appoint an experienced Design Quality Engineer into their business.
The Design Quality Engineer provides quality function support to the development, maintenance, and changes of design projects. The Design Quality Engineer will ensure compliance with and maintenance of the company’s QMS and regulatory requirements within design documents, records, and processes.
The Design Quality Engineer will draft and execute required design project documentation such as FMEAs, Validation Protocols, DMRs, Verification testing, and technical report writing to support the execution of design projects.
The Design Quality Engineer will own and lead the completion of NCs and CAPAs associated with design projects.
ESSENTIAL DUTIES & RESPONSIBILITIES:
- Represent the quality function within the design and development team.
- Support the design team by drafting, implementing, and executing procedures, records, and protocols for design and development projects.
- Participate in design team meetings to draft, review, and implement design projects.
- Ownership of design NCs & CAPAs, lead investigations, root cause analysis, and corrective action implementation.
- Develop metrics/KPIs within the QARA team to implement, maintain, and improve the company’s QMS from a design and development perspective.
- Support external audit activities.
KNOWLEDGE AND SKILLS TO BE SUCCESSFUL IN THE JOB:
Education Required: Bachelor’s degree in Science, Engineering, Quality, or a related subject.
Years of related experience: 2+ years’ experience in a regulated environment.
Quality systems, auditing, and supplier/purchasing controls, engineering or equivalent experience desirable (Medical Device, automotive, aerospace, electronics Med Device preferable).
REQUIREMENTS:
- Knowledge of regulatory requirements including ISO 14971, ISO 13485, and FDA Quality System Regulations.
- Electronic technical knowledge and experience.
- Experience of creating and executing Design/NPI – New Product Introduction projects, preferably within the quality function.
- Experience of drafting and implementing Design/Quality documents and protocols: e.g., Validation, FMEA, test documents, etc.
- Must be able to work within a team in a dynamic environment and interact effectively at all levels and across all functions within the organization.
- Flexible mindset to adapt to evolving requirements within a small, dynamic work environment.
- High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel, and PowerPoint packages.
- Excellent English (both oral and written).
- Experience in interacting with regulatory agencies (FDA, MHRA, TUV, etc.) advantageous.
- Ability to be the voice of quality when dealing cross-functionally with development & other departments.
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Design Quality Engineer employer: ZipRecruiter
Contact Detail:
ZipRecruiter Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Design Quality Engineer
✨Tip Number 1
Familiarize yourself with the specific regulatory requirements mentioned in the job description, such as ISO 14971 and ISO 13485. Understanding these standards will not only help you in interviews but also demonstrate your commitment to quality in the medical device industry.
✨Tip Number 2
Highlight any experience you have with drafting and executing design documents like FMEAs and Validation Protocols. Be prepared to discuss specific projects where you successfully implemented these processes, as this will show your practical knowledge and expertise.
✨Tip Number 3
Engage with professionals in the medical device field through networking events or online platforms. Building connections can provide insights into the company culture and expectations, which can be invaluable during the interview process.
✨Tip Number 4
Prepare to discuss your experience with non-conformances (NCs) and corrective actions (CAPAs). Being able to articulate how you've led investigations and implemented solutions will showcase your problem-solving skills and your ability to maintain quality standards.
We think you need these skills to ace Design Quality Engineer
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Design Quality Engineer position. Understand the key responsibilities and required skills, especially those related to quality systems and regulatory requirements.
Tailor Your CV: Customize your CV to highlight relevant experience in quality engineering, particularly in regulated environments. Emphasize your familiarity with ISO standards and any specific projects you've worked on that align with the job requirements.
Craft a Strong Cover Letter: Write a compelling cover letter that showcases your passion for quality engineering and your understanding of the medical device industry. Mention specific experiences that demonstrate your ability to lead NCs and CAPAs, as well as your teamwork skills.
Highlight Technical Skills: In your application, be sure to mention your proficiency with Microsoft Office tools and any electronic technical knowledge you possess. This is crucial for the role, so provide examples of how you've used these skills in past positions.
How to prepare for a job interview at ZipRecruiter
✨Showcase Your Regulatory Knowledge
Make sure to highlight your understanding of regulatory requirements such as ISO 14971 and ISO 13485 during the interview. Discuss any relevant experiences you have had with FDA Quality System Regulations, as this will demonstrate your capability to navigate the compliance landscape.
✨Prepare for Technical Questions
Expect questions related to design project documentation like FMEAs, Validation Protocols, and Verification testing. Be ready to discuss specific examples from your past work where you successfully drafted or executed these documents.
✨Emphasize Team Collaboration
Since the role requires working closely with design teams, be prepared to share examples of how you've effectively collaborated in a team setting. Highlight your ability to communicate across functions and adapt to dynamic environments.
✨Demonstrate Problem-Solving Skills
Be ready to discuss your experience with Non-Conformances (NCs) and Corrective and Preventive Actions (CAPAs). Share specific instances where you led investigations or implemented corrective actions, showcasing your analytical and problem-solving abilities.
