Sigmar Recruitment have a fantastic opportunity for an experienced Quality Engineering Specialist to work with our innovative client in Cork. This role is initially a 12 month fixed term contract and offers a competitive package.
The successful candidate will be responsible for providing support to regulatory affairs and legal manufacturer representatives to ensure all objectives associated with MDR implementation are met. You will also be responsible for providing technical oversight, driving relevant activities and ensuring local validation activities meet the required regulatory standards.
Core Duties & Responsibilities:
- Work closely with Regulatory Affairs and Legal Manufacturer personnel to ensure all manufacturing location validation and processes meet regulatory requirements and legislation
- Conduct a technical review, update manufacturing location process validation documents to meet MDR requirements as needed
- Provide technical oversight to department representatives in relation to regulatory requirements associate with the MDR
- Provide manufacturing location technical support to Regulatory Affairs and Legal Manufacturer personnel to ensure documentation requests for product/ manufacturing processes are fulfilled for all regulatory agencies
- Act as site liaison for all MDR related activities
- Provide change impact assessment/ feedback on manufacturing location change controls relating to processes, equipment and product changes to maintain validated state of systems
- Degree in Science, Engineering or Biomedical Engineering
- Minimum of 2 years experience working within a medical device environment
- In-depth knowledge of regulatory requirements relating to Europe and USFDA
- Exceptional analytical and problem solving skills
- Excellent technical knowledge
- Ability to interface with both technical and non-technical parties of all levels
- Strong ability to work independently with minimal supervision
- Outstanding communication and interpersonal skills
If this sounds like the role for you, call Rebecca on 021-4847137 or email your CV direct to email@example.com, TODAY!
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