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Senior Quality Engineer - Shannon

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Salary: £55,000.00 per annum


Greater London, London

Job Advertiser

FRS Recruitment
Registered: 13 Dec '17
Postings: 0
Followers: 3, Following: 0

Job Reference: FRS54103

Job Duration:

Start date:

Description:

An excellent opportunity for an experienced Senior Quality Engineer to join an expanding medical device manufacturing facility in Shannon.

This is a fantastic opportunity for an experienced Quality Engineer to join a well-established company with exciting growth plans. Within this position youwill be responsible for leading and supporting projects ensuring all quality activities completed in accordance with relevant statutory requirements.


What is in it for you?

* Permanent Position
* Monday to Friday!
* Excellent opportunitiesfor career progression and advancement.
* Attractive salary and benefits package on offer
* Hybrid working opportunities.* Family feel culture but has the support of a larger global organisation

Responsibilities: (A Snapshot…)

* Manage both Product and Process Verification and Validation activities as related to the specific scope of planned work associated with the asset / process in question.
* Lead Quality Engineering support on project activities i.e.: Design Improvements, Supplier Transfer's, Cost Improvements, and New Product Introductions etc.
* Manage activities within the project teams ensuring that project planning is completed correctly with full evaluation and engagement from the necessary resources.
* Lead investigation of quality issues should they arise during day-to-day production or within projects - work with project leaders, quality, materials, manufacturing, and suppliers to resolve issues.
* Liaise with the Supplier Quality group to ensure Supplier Approval Requirements are met.
* Responsible for ensuring conformance with current equipment, process, and systems validation regulations.



Requirements:

* BE/BS Degree. A Post-graduate qualification in Quality Assurance is preferable although not BE/BSDegree. A Post-graduate qualification in Quality Assurance is preferable although not mandatory.
* 5 years' experience in a similar capacity in a regulated industry (i.e., FDA /ISO).
* 3 years Supervisory / Management experience in a Medical Device /Pharmaceutical regulated industry desirable.
* Experience working in both an FDA and European regulatory environment is preferred with an in-depth knowledge of 21 CFR 820, CFR 11 and European regulations associated with the medical device industry.
* Athorough understanding of GMP/ISO and validation regulations.
* Experience of regulatory landscape with respect to FDA, CE Marking plus other regulatory territories while not mandatory is considered beneficial.
* Minimum certification to Green Belt Lean Six Sigma (or recognized equivalent qualification).



Next Steps:

APPLY NOW!

Click Apply now to review the full details and job spec for this fantastic opportunity.

Industry: Manufacturing and Production

Salary: Negotiable, Healthcare, Pension,

Salary Benefits: Negotiable, Healthcare, Pension,

Vacancy Type: Permanent

Job Skills: Quality Engineer, ISO 13485, medical device manufacturing

Contact Name: Kerry Rickard

Website: -

Direct Application URL: -

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Position Details

Advert Ref: #3016268
Posted: 31 Jan '23
Visits: 16