Senior Quality Engineer
Posted on Jan 4, 2022 by Real Staffing Group
Job title: Senior Quality Engineer
Location: Spiddal, County Galway
Benefits: Excellent salary, pension, healthcare and career progression.
The position of Senior Quality 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.
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)
o New product introductions
o Development and approval of new product documentation.
o 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
- Minimum degree in Quality Engineering, Manufacturing engineering, Life science or related field.
- Minimum of 1 years. experience at Senior Engineer level within the Medical Device Industry including at least 2 years.
- 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 by email or call and I am happy to help.
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 | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales
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£57.8k - £61.4k Annual