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For Companies At a Glance
- Tasks: Join our team as a Quality Engineer, supporting design projects and ensuring compliance with quality standards.
- Company: Work for a leading Medical Device Manufacturer making a real impact in healthcare.
- Benefits: Enjoy a dynamic work environment with opportunities for growth and development.
- Why this job: Be part of innovative projects that improve lives while collaborating with talented professionals.
- Qualifications: Bachelor’s degree in Science, Engineering, or related field; 2+ years in a regulated environment required.
- Other info: Experience with ISO standards and regulatory agencies is a plus!
The predicted salary is between 36000 - 60000 £ per year.
Job Description
Our client, a leading Medical Device Manufacturer, is looking to appoint an experienced New Product Development Quality Engineer into their business.
The Design Quality Engineer provides quality function support to the development, maintenance, and changes of design projects. The New Product Development Quality Engineer will ensure compliance with and maintenance of the company’s QMS and regulatory requirements within design documents, records, and processes.
The New Product Development 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 New Product Development 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, leading 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 a relevant field such as Science, Engineering, Quality, or equivalent 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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New Product Development - Quality Engineer employer: ZipRecruiter
Contact Detail:
ZipRecruiter Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land New Product Development - Quality Engineer
✨Tip Number 1
Make sure to 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 during interviews but also demonstrate your commitment to quality in the medical device industry.
✨Tip Number 2
Highlight any experience you have with drafting and implementing design documents like FMEAs and Validation Protocols. Be prepared to discuss specific projects where you successfully executed these tasks, as this will show your hands-on expertise in New Product Development.
✨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 NCs and CAPAs in detail. Being able to articulate how you've led investigations and implemented corrective actions will showcase your problem-solving skills and your ability to maintain compliance in a regulated environment.
We think you need these skills to ace New Product Development - Quality Engineer
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description and understand the key responsibilities and requirements of the New Product Development Quality Engineer position. Tailor your application to highlight relevant experiences that align with these aspects.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in regulated environments, particularly in quality systems and design projects. Mention specific examples of your work with FMEAs, validation protocols, and any relevant metrics or KPIs you have developed.
Showcase Technical Skills: Demonstrate your proficiency with Microsoft Word, Excel, and PowerPoint in your application. If you have experience with regulatory requirements like ISO 14971 and ISO 13485, make sure to include this information as it is crucial for the role.
Craft a Strong Cover Letter: Write a compelling cover letter that not only summarizes your qualifications but also expresses your passion for quality engineering in the medical device field. Use specific examples to illustrate how you can contribute to the company's QMS and design projects.
How to prepare for a job interview at ZipRecruiter
✨Show Your Knowledge of Regulatory Standards
Make sure to brush up on ISO 14971, ISO 13485, and FDA Quality System Regulations. Being able to discuss these standards confidently will demonstrate your expertise and understanding of the quality requirements in the medical device industry.
✨Prepare for Technical Questions
Expect questions related to design project documentation like FMEAs, Validation Protocols, and Verification testing. Be ready to provide examples from your past experience where you successfully executed these documents.
✨Demonstrate Team Collaboration Skills
Since the role involves working closely with design teams, be prepared to discuss how you've effectively collaborated in previous projects. Highlight any experiences where you led investigations or implemented corrective actions.
✨Exhibit Flexibility and Adaptability
The job requires a flexible mindset to adapt to evolving requirements. Share examples of how you've successfully navigated changes in project scopes or priorities in a dynamic work environment.
