Senior Quality Lead Assurance Engineer


Premium Job From Real Staffing

Recruiter

Real Staffing

Listed on

2nd September 2020

Location

Galway

Salary/Rate

£49698 - £58734

Type

Permanent

Start Date

ASAP

This job has now expired please search on the home page to find live IT Jobs.

Job title: Senior Quality Assurance Lead EngineerLocation: Spiddal, County GalwayBenefits: Excellent salary, pension, healthcare and career progression. Job overview:The position of Senior Quality Assurance Lead Engineer requires an experienced and proven candidate with a background in Quality Control, Quality Assurance and Regulatory compliance of Medical Devices. The successful candidate will work as part of a team to maintain high quality/performance standards across the company.Reporting to the Director QA/RA, the position will be challenging and will require an ability to work autonomously. Responsibilities: Collaborate with the Project teams to facilitate the successful execution of the Design Services process and Commercialization of new products. Provide expertise in the areas of Quality Assurance, Design Controls, Risk Management, Statistical Techniques, and Regulatory Compliance and SubmissionsLead and Support Design Services engineering activities (including but not limited to)o New product introductions o Development and approval of new product documentation.o Qualification of new suppliersMaintenance of fully compliant documents and proceduresManagement of training/development needsCo-ordination of QC inspection schedules aligned to support and deliver Quality /Manufacturing/Design Services -NPI/ Customer deadlinesManagement of environmental monitoring activities, Endotoxin (LAL) and Product Bioburden sampling programManagement of QC Inspection record review / release, including final product releaseComplete customer and supplier notification change assessments and appropriate follow on actionsCo-ordinate Customer Complaint processing (investigations and customer response)Co-ordinate Internal audits of Clean Room (Line audits)Act as delegate for Quality Manager when requiredPerform additional duties as required by the role and management Role Requirements:Minimum degree in Quality Engineering, Manufacturing engineering, Life science or related field.Minimum of 5 yrs. experience at Senior Engineer level within the Medical Device Industry including at least 2yrs. proven People management experience.Proven record of handling multiple tasks simultaneously and ability to manage project timelines If you are interested in applying or have any questions about the role and company contact me on the details provided and I will be happy to help. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

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