We are looking for a QS Technical Assistant to provide QS technical assistance to established procedures within the QS Department. This role ensures that Documentation, Change Control, NCR/CAPA/Complaints, Product Release, and Electronic Training System activities are completed in a timely manner.
The successful applicant will be responsible for:
* Monitoring and progressing changes in the Product Lifecycle Management (PLM) system to ensure compliance with established quality procedures.
* Performing Document Control activities to ensure compliance with established quality procedures.
* Performing activities as required by established policies and procedures to ensure compliance with necessary regulatory bodies in the areas of: Corrective and Preventive Action (CAPA), Complaint and Non-conformance Report (NCR).
* Supporting the QS Technician Team Leader, as required, to perform evaluation of documentation relating to items manufactured/serviced to ensure compliance with quality requirements.
* Supporting Electronic Training System activities to ensure compliance with established quality procedures.
* Advising design and manufacturing teams in Change Control process to minimise future risk to their processes.
* Providing reports to management to enable them to monitor system performance.
* Identifying and collaborate in the implementation of changes to the Quality System to increase efficiency and/or effectivity whilst ensuring compliance with applicable regulations.
* Supporting and perform training throughout the company to maintain awareness of the Quality System requirements.
We are looking for someone who has:
Education / Qualifications:
* GCSE level Science, Eng., or Quality orientated qualification, or proven experience in a similar role
Behaviours / Skills / Experience:
* Minimum of 1 years' experience working within the medical device, pharmaceutical industry, or other similar highly regulated industry.
* Experience of electronic change control systems and quality investigational activities
* Awareness of ISO13485:2003, Medical Device Directive MDD 93/42/EEC and FDA QSR Part 820
* Computer literate to include MS Word and Excel and MRP
* Ability to multitask and prioritise with planning and organisation skills.
* Good inter-personal skills and the ability to communicate well in English both written and orally.
* Good record/documentation skills.
* Works with integrity, customer focus, accountability and teamwork.
We offer:
Hybrid Working (usually 2 days at home and 3 days onsite)
Bonus Scheme
Generous Pension Scheme
Life Assurance 4 x salary
Private Medical Insurance
BUPA dental cover
25 days Annual Leave (plus bank holidays)
Employee Assistance Programme
About ATL Technology
ATL Technology is a fast-growing provider of outsourced design, development and manufacturing services to the medical device market, and its UK site is based in St Mellons, Cardiff.
We believe that there is a better way to bring medical devices to market and we use an engineer-to-engineer approach to develop custom interconnect solutions for medical devices that improve the quality of one's life. It is our mission to be the leading provider of custom engineered solutions for top medical device manufacturers.
Aside from our site in the UK, we also have operations in China, Costa Rica, Taiwan and the USA; plus remote staff in strategic global locations... and we're growing!
Other information
You will be required to provide evidence of your eligibility to work and reside in the UK, in accordance with the requirements of Section 15 of the Immigration, Asylum and Nationality Act 2006. The role that you are applying for may require you to undertake a Disclosure & Barring Service (DBS) check.
At Gyrus Medical Ltd (An ATL Technology Company), we have a dedicated in-house recruitment team that cover all areas of the business. As a backup, we have a preferred supplier list (PSL) of vetted suppliers and as such, are unable to accept unsolicited CVs from recruitment agencies or search firms outside of our PSL (which is now closed to new suppliers). Please note that Gyrus or ATL will not be responsible for any fees, charges or terms associated with any such CVs. CVs will only be accepted from approved agencies where terms and conditions have been agreed and we have instructed them to work on specific positions. Agencies will be contacted by the recruitment team should we wish to engage their services. We do not take sales calls and politely request that you refrain from directly approaching the recruitment team or line managers and remove Gyrus Medical Ltd from your mailing list. Thank you for your understanding.
Gyrus Medical Ltd (an ATL Technology Company) is an equal opportunity employer.
Job Posted by ApplicantPro