Quality Engineer

Recruiter
SRG
Location
Borehamwood
Salary
£30000 - £45000/annum bonus, pension, healthcare
Posted
17 Jun 2017
Closes
17 Jul 2017
Sector
Engineering
Contract Type
Permanent
Hours
Full Time
Quality Engineer - £Competitive - SW London

SRG are currently recruiting for a Quality Engineer to join a well establishedMedical Device company in South West London on a permanent basis.

This position is for a quality engineer based at whose main responsibilities are compliance, maintenance and improvement of the quality management systems processes to ISO 13485,

The Quality Engineer is expected to:
o Evaluate non-conformance, out of specification results, and non-conforming material using a risk based approach to classify non-conformance and disposition of material
o Perform investigations, evaluate and interpret data, identify root causes and implement corrective and preventive action plans
o Author, review and execute validation plans, change control, and risk management activities
o Author, review and approve quality management system processes and documentation. Maintain compliance site wide at the highest level in all quality system processes
o Perform internal and supplier audits and when required host (or act as SME) for external regulatory audits

Duties and Responsibilities:

* Ensuring compliance and maintenance of quality and regulatory standards including ISO 13485, ISO 9001, 21CFR820
* Evaluate non-conformances, out of specification results and non-conforming material in order to classify non-conformance and disposition material. Author, and / or approve non-conformance reports
* Owner of corrective and preventive actions; develop corrective and preventive action plans and implement these within a given timescale to eliminate the root cause of the NC
* Utilise Quality Engineering tools and techniques to perform and document full investigations, evaluate and resolve quality issues, and to enhance continuous improvement
* Lead quality department projects to ensure the highest standards of compliance and on time delivery. Represent QA on site wide project teams
* Review, execution and approval of Quality System processes including, Risk Management (pFMEA, risk assessment), and Change Control
* Review and approve batch manufacturing records and laboratory test data and disposition material
* Performs internal audits as per the audit schedule
* Leads meetings, takes minutes and reports actions. Follows up actions to support timely closure. Reports issues to Quality Management

Skills & Experience:

* Ideally Degree level education and / or equivalent experience in quality management and the application of ISO 9001, ISO 13485, 21CFR820
* Six Sigma green belt qualified and a demonstrated ability in the use of quality engineering tools and techniques and data interpretation.
* Experience in implementation, management and improvement of Quality System processes (e.g. Calibration / Audit / CAPA / Change Control / Validation) gained in a quality assurance function within the medical device industry.
* Experience in the use of quality engineering tools to perform investigations, analyse data and identify root causes.
* Experience of implementation and execution of robust corrective and preventive action plans to meet planned timelines.
* Sufficient experience gained in a quality engineering environment to demonstrate a thorough understanding of a risk based quality approach, and material disposition.
* A practical working knowledge of implementation of change control, and of all aspects of process and computer systems validation.
* Demonstrated ability to lead multiple projects and motivate cross functional teams whilst ensuring that deadlines are met.
* Competent auditor and experience of supplier management desirable.
* Experience in hosting or acting as SME during external regulatory audits.

For more information, please call Chloe Pulo on (Apply online only) or email:

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency