Quality Assurance Specialist
1 week ago
We are seeking a highly skilled Quality Specialist to join our Operations Compliance team at Eakin Healthcare. As a key member of our team, you will play a critical role in ensuring the quality and compliance of our medical devices.
Key Responsibilities- Develop and maintain regulatory compliant Quality Management System (QMS) documentation and training materials.
- Review and analyze QMS reports, quality metrics, and customer feedback to identify areas for improvement.
- Collaborate with cross-functional teams to ensure quality and regulatory requirements are met during new product introduction projects.
- Lead internal audits and assist with third-party audits and inspections.
- Develop and implement quality metrics and track key performance indicators.
- Support the Quality Manager in achieving annual objectives and ensuring compliance with regulatory standards.
- A level or equivalent and/or, a minimum of five years experience in medical device manufacturing.
- Proven experience in a volume manufacturing regulated environment in a Quality based role, with compliance experience to a quality standard.
- Strong interpersonal and communication skills, with the ability to build effective professional working relationships.
- Meticulous with high levels of attention to detail, and a strong command of written English.
- Excellent verbal communication skills, and excellent organisational and planning skills to deliver efficient QMS based outputs.
- Experience of working in a product/batch release role in the medical device/pharmaceutical industry.
- 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).
You will work closely with our R&D team to ensure quality and regulatory requirements are met during new product introduction projects, and with our production team 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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