Job Description
My client a specialist in the manufacture of medical devices are seeking a quality systems engineer.
The Main duties include:
·Establishing working methods and documentation
·Reviewing and updating Quality System Records
·Reviewing Internal Audit Reports and ECN's
·Keeping SOP's and Technical Files up-to-date
·Writing Internal Process SOP's
·Keeping Training Records up-to-date
·Making sure Customer Complaint Records are completed and closed out
·External and Internal Auditing
·Corrective Action Management
·Liaise with contractors and manufacturing controls
Required requirements
Successful candidates will have experience within the medical device industry (preferably within the orthopedic industry) and have a knowledge of ISO9001. Ideally you will also have knowledge of ISO13485.
Attention to detail is essential. You must be a strong problem solver with the ability to work with staff at differing levels of the organisation and without supervision.
You must have competence to assess and upgrade procedures and systems.