Quality Assurance Specialist
1 week ago
We are seeking a highly skilled Quality Assurance Specialist to join our Operations Compliance team at Eakin Healthcare. As a key member of the team, you will be responsible for ensuring the quality and regulatory compliance of our medical devices.
Key Responsibilities- Develop and implement quality management systems to ensure compliance with regulatory requirements.
- Conduct quality audits and investigations to identify and address any non-conformities.
- Collaborate with cross-functional teams to ensure quality and regulatory requirements are met.
- Develop and maintain quality metrics and reports to track performance.
- Provide training and guidance to colleagues on quality and regulatory requirements.
- Minimum of 5 GCSEs or equivalent, including Math and English.
- Minimum of three years experience in a medical device manufacturing environment.
- Proven experience in a quality-based role with compliance experience to a quality standard.
- Strong interpersonal and communication skills.
- Ability to work well in a team and unsupervised.
- Experience of working in a regulated manufacturing environment (e.g., ISO13485, ISO14971, MDD, EU MDR, MDSAP).
- Experience of using an electronic quality management system (eQMS).
- Experience in good documentation practices (GDP).
- Experience in a medical device / life sciences environment.
You will be working closely with the R&D team to ensure quality and regulatory requirements are met during new product introduction projects. You will also be liaising with production personnel at all levels to ensure requirements for quality are defined and met.
Additional InformationOccasional travel to other companies within the group and to supplier premises may be required.
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