Posted: 23 January
Offer description
Job Title: Quality Assurance Specialist
Benefits:
* Good salary
* Healthcare
* Pension
* 25 days holidays
* Opportunity to grow your career with a Medical Device company working on projects from concept
Summary:
The Quality Systems specialist role involves supporting the development and implementation of the Quality Management System with our Medical Device client to maintain 2017/745(MDR), ISO 13485, ISO 14971, ISO 9001, and FDA QSR standards and requirements.
Responsibilities:
* Aid the team in the development, implementation, and maintenance of the Quality Management System
* Support the operation of the Quality Management System and documentation control, including Change Controls, CAPAs, Non Conformances, Training, Internal, Vendor, and Third-Party Audits
* Participate in product and process risk assessments
* Perform Internal Audits or Supplier Audits
* Perform Supplier Qualification and monitoring as requested
* Drive continuous improvement initiatives within the QMS
* Partake in Customer-specific or internal quality projects
* Perform QA Verification of activities performed in production
* Review and update Quality System documentation (procedures, reports) as requested
* Partake in activities for design and process validation
* Take part in Notified Body Audits and Audit preparation as requested
* Generate Quality Metric reports as required and assist in any other data compilation as requested
Requirements:
* Qualifications: Third-level qualification in natural sciences (Certificate, Diploma, Degree level)
* 3+ years of experience in Quality and Good Documentation Practices in a highly regulated industry (pharma, medical devices)
* Good planning and organizational skills
* Good communication (oral and written)
* Hardworking and highly motivating individual, with good attention to detail
Skills:
* Quality
* CAPAs
* Audits
