Quality Specialist
- Employer
- Actalent
- Location
- Dublin (City), Leinster (IE)
- Salary
- Attractive Day Rate
- Start date
- 8 Nov 2021
- Closing date
- 8 Dec 2021
View more
- Discipline
- Clinical Research, Quality
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Experienced (non-manager)
Job Details
The Medical Device Combination Product Specialist is to provide quality oversight and support for commercial and clinical combination products from introduction throughout the product and design control lifecycle and the associated Quality System.
Responsibilities
- Facilitates local and global changes with respect to the product and design control
- Ability to work cross functionally with Quality Assurance, Tech Ops, Development
- Comply with Alexion’s quality assurance requirements
- Support the development of the design control quality plan in line with applicable regulations for combination products including Planning, Design and Development, Validation, Verification, Risk Management and Technology Transfer
Requirements
- Minimum of 4+ years’ experience in Quality with medical device or combination products in a regulated environment
- Familiarity with SAP and Trackwise would be desirable
- Knowledge of the regulatory and compliance requirements of design control for medical devices and/or combination products (e.g. FDA QSR 21 CFR Part 4 and 820 / ISO 13485 and Regulation (EU) 2017/745).
Company
About Actalent
Actalent connects passion with purpose. Our scalable services and talent solutions drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world.
Actalent’s global footprint and flexible delivery models ensure access to specialized talent where and when you need it. We promote consultant engagement through professional development and provide experiences to ensure continuous learning. Our people are the difference.
Our expertise spans capabilities in engineering including product and manufacturing, systems and software, construction management, environmental, architecture and civil; and power and utilities. We focus on sciences capabilities in laboratory sciences, healthcare, and clinical research.
Actalent is an operating company of Allegis Group, the global leader in talent solutions.
- Website
- https://www.actalentservices.com/en-gb
- Telephone
- +44 0 1344 383 100
- Location
-
Maxis 2 ,
Western Rd
Bracknell
Berkshire
RG12 1RT
GB
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