The Quality Systems specialist role will involve supporting the development and implementation of the Quality Management System at in order to maintain 2017/745(MDR)ISO 13485, ISO 9001 and FDA QSR standards and requirements. The QMS includes medical device design and Development, Manufacturing and distribution and secondary packaging activities.
Your new Role
- Aid the team in the development implementation and maintenance of the Quality Management System.
- Support the operation of the Quality Management System & Documentation control such as:
- Change Controls, CAPA and NCR, Employee Training, Internal and Vendor Audits, Participate in product and process risk assessments.
- Perform Internal Audits or Supplier audits as per plan.
- Perform Supplier Qualification as requested.
- Drive continuous improvement initiatives based on quality initiatives.
- 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.
- 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.
Customer specific tasks:
- Ensure protection of client confidential information in accordance with non-Disclosure agreements.
- Specific duties associated with client services are specified in client contracts/service agreements.
- Perform all tasks in compliance with company policies and procedures.
- Support Key Projects and other duties as assigned.
What you need to succeed :
- Qualifications: Third level qualification in natural sciences (Certificate, Diploma, Degree level)
- Experience in Quality and Good documentation Procedures in a highly regulated industry (pharma, medical devices)
- Good planning and organisational skills.
- Good communication (oral and written).
- Hardworking and highly motivating individual, with good attention to detail.
- Appropriate computer skills. MS Office.
- Ability to work both independently and as part of a team.
