Search Jobs

Hold CTRL to choose multiple sectors (up to 3)


Hold CTRL to choose multiple sectors (up to 3)

Design Controls Quality Specialist job in Woodstock

  • Show me jobs like this one
  • More jobs from this recruiter
  • Email this job to a friend
  • Print this job
Job Ref:  204602025
Employer:  cv-library.co.uk
Industry:  Civil and Structural
Job Type:  Permanent
Country:  United Kingdom
City:  Woodstock
Post Code:  SA63
24/10/2016 10:55
An exciting opportunity for an experienced Design Control Quality Specialist has arisen with a Major Medical Device Manufacturer.

Design Control Quality Specialist

The role is to ensure projects comply with all requirements of Design Controls
(to include CFR Part 820). This will mean working closely with R & D and the Customer in order to achieve this.

The role is key to provide Quality oversight, input and guidance on a number of projects to include:

* Responsible for verifying compliance to quality and regulatory requirements for device development and design control

* Responsible for providing quality and compliance guidance to associates in Research & Development and in Industrialisation/Operations

* Support Associates at all levels of the business to assure required documentation is completed in sequence and in a timely manner and to support continued business compliance and success

* Primarily responsible for all quality aspects for development projects and design control with key customer(s)

* Provide quality input during development and design control phases of projects in meetings, supplier visits and observing within production.

Key Responsibilities

* Review and approve device development documents (e.g. design input requirements, design reviews, design verification test protocols, design verification test reports etc. ) for both new devices undergoing development and for existing devices undergoing continuous improvement

* Review and approval of qualification/validation protocols and qualification/validation reports for tools, equipment, facilities, utilities, test methods and computerised systems for the industrialisation of products and processes

* Interface with customers to understand their requirements and present the company processes and documentation to them with confidence and assertiveness

* Interface with auditors (external and internal) to confidently present processes and records to demonstrate quality compliance

Knowledge and Expertise

* Sound knowledge of current regulatory requirements for medical device (alternatively pharmaceutical) development and design control

* Knowledge of validation as well as experience with Best Practice (preferable)

* Proven experience working in medical devices.

* Knowledge of Current Good Manufacturing Practices (cGMP) requirements.


* Degree level education in scientific discipline (or equivalent experience)

Job Title: Design Controls Quality Specialist

Reference No: 228392

Location: Woodstock
Job Type: Permanent

Please apply to Rachel Oliver, Senior Consultant;; (Apply online only)

RHL is a specialist Recruitment Consultancy within Design, Engineering & Manufacture talent acquisition.

Recruitment Holdings Ltd (RHL) acts as an Employment Business and as an Employment Agency
Copyright © Rengineeringjobs.com Job Board 2011  | Powered by JobMount Job Board Software