Senior Quality Engineer

1 day ago

Galway, United Kingdom Real Staffing Full time

**Job title**: Senior Quality Engineer

**Location**: Spiddal, County Galway

**Benefits**: Excellent salary, pension, healthcare and career progression.

**Job overview**:
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 Submissions
- Lead and Support Design Services engineering activities (including but not limited to)
- New product introductions
- Development and approval of new product documentation.
- Qualification of new suppliers
- Maintenance of fully compliant documents and procedures
- Management of training/development needs
- Co-ordination of QC inspection schedules aligned to support and deliver Quality /Manufacturing/Design Services -NPI/ Customer deadlines
- Management of environmental monitoring activities, Endotoxin (LAL) and Product Bioburden sampling program
- Management of QC Inspection record review / release, including final product release
- Complete customer and supplier notification change assessments and appropriate follow on actions
- Co-ordinate Customer Complaint processing (investigations and customer response)
- Co-ordinate Internal audits of Clean Room (Line audits)
- Act as delegate for Quality Manager when required
- Perform 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 1 yrs. experience at Senior Engineer level within the Medical Device Industry including at least 2yrs.
- Proven record of handling multiple tasks simultaneously and ability to manage project timelines

Looking forward to hearing from you.

Real 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 andWales

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