Real Staffing Group
Our client is a rapidly growing medical device manufacturer operating in life sciences internationally – with a portfolio of cutting edge products ranging from surgical, equipment to consumables. Reporting to the Quality Manager the Quality Assurance Engineer will provide a quality assurance function at the site.
This will include:
Liaise with production and supplier personnel as appropriate on quality issues.
The Quality Assurance Engineer will maintain and develop knowledge of quality improvement techniques.
Undertake quality improvement projects.
Responsible for producing quality specifications, purchasing specifications and procedures and for their consistent implementation.
The Quality Assurance Engineer will be responsible for Validation of new or existing processes (where appropriate) in conjunction with process engineering.
Responsible for investigating and resolving quality issues and providing production support.
Responsible for liaising with production, quality, supplier and technical personnel to identify and implement quality tools (eg Six Sigma, Lean)
The Quality Assurance Engineer will be responsible for supporting the internal quality audit function.
Responsible for preparing summary reports for management review and other formal review meetings.
Responsible for coordinating activities relating to CAPAs/NCRs & SCARs.
Responsible for maintaining IFS QM module.
Responsible for adhering to the requirements defined within the Company’s health & safety, environmental and quality policies and systems.
Responsible for addressing QA issues as directed by the Quality Manager.
The Quality Assurance Engineer will meet the requirements regarding Quality and GMP standards as detailed in the Company Quality policy.
HNC/HND or equivalent in engineering or related Quality discipline and/or relevant experience gained within a manufacturing environment.
Quality Assurance experience, preferably gained within the medical devices industry.
Regulatory affairs experience a benefit but not essential.
Knowledge of medical device regulations (eg FDA, ISO 13485, MDD or EU MDR).
Ideally trained internal auditor to ISO 13485 (not a deal breaker).
Knowledge of Six Sigma techniques an advantage.
Able to work in cleanroom environment.
Computer literate with knowledge of Microsoft Office software an advantage.
Willing to participate in Developmental training programs.
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales