New Product Development – Quality Engineer

TN United Kingdom; Greater London; On-site; GBP 40,000 - 70,000; Full time

Job summary

An established industry player in medical devices seeks an experienced Design Quality Engineer to enhance their quality assurance processes. This role involves supporting design projects, ensuring compliance with regulatory standards, and leading investigations into quality issues. The ideal candidate will have a strong background in quality management systems and regulatory requirements, with a focus on continuous improvement. Join a dynamic team dedicated to innovation and excellence in product development, where your expertise will directly impact the quality and safety of medical devices.

Qualifications

• 2+ years’ experience in a regulated environment.
• Knowledge of ISO 14971, ISO 13485, and FDA QSR.

Responsibilities

• Represent the quality function within the design and development team.
• Lead investigations and corrective actions for design NCs & CAPAs.

Skills

Regulatory Compliance

Quality Management Systems (QMS)

Root Cause Analysis

Technical Report Writing

FMEA

Verification Testing

Microsoft Office Suite

Excellent English Communication

Education

Bachelor's Degree in Science

Bachelor's Degree in Engineering

Bachelor's Degree in Quality

Job description

Social network you want to login/join with:

New Product Development – Quality Engineer, Buckinghamshire

Client:

Cpl Life Sciences

Location:

Buckinghamshire, United Kingdom

Job Category:

-

EU work permit required:

Yes

Job Reference:

32d774bef1ad

Job Views:

12

Posted:

28.04.2025

Expiry Date:

12.06.2025

Job Description:

Overview

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. They 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 reports to support design projects.

The Engineer will own and lead the completion of NCs and CAPAs associated with design projects.

ESSENTIAL DUTIES & RESPONSIBILITIES:

1. Represent the quality function within the design and development team
2. Support the design team by drafting, implementing, and executing procedures, records, and protocols for design and development projects
3. Participate in design team meetings to draft, review, and implement design projects
4. Ownership of design NCs & CAPAs, lead investigations, root cause analysis, and corrective actions
5. Develop metrics/KPIs within the QARA team to improve the company's QMS from a design and development perspective
6. Support external audit activities

Knowledge and Skills to be Successful:

• Bachelor's degree in Science, Engineering, Quality, or related field
• 2+ years’ experience in a regulated environment
• Knowledge of regulatory requirements including ISO 14971, ISO 13485, and FDA QSR
• Experience with design and NPI projects, drafting and implementing quality documents
• Proficiency with Microsoft Office Suite
• Excellent English communication skills
• Experience with regulatory agencies (FDA, MHRA, TUV) is advantageous

Application Process:

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