The Company: The company is a newly created entity which will work closely with an established medical device distribution company to create its own label product lines for the orthopaedic community.
The Position: They are now looking for a Quality Manager on a permanent basis ideally in Hertfordshire or within driving distance to Stevenage with experience in the Medical Devices Industry.
Why Should You Apply?
- You will be part of a growing company where autonomy is valued.
- You'll be part of a small, friendly team.
Basic salary: Negotiable
Based Hertfordshire or within driving distance to Stevenage
Products: Orthopaedic devices
- Qualified in Engineering ideally (NVQ / HNC / HND / Degree or similar) OR Qualified by experience.
- Knowledge of ISO13485 within Medical Devices manufacturing
- Knowledge of MDR and UKCA certification (technical files)
- Previous experience as a Quality Manager
- Have previous experience of the auditing process.
- Capable of fully managing a QMS.
- Have excellent communication skills both verbal and written
- Be self-motivated and have a positive attitude
- Good problem-solving skills.
With experience in the Medical Devices industry, your main duty will be to create the Quality Management System (ISO 13485) as well as Technical Files for Class I, Class IIa, Class IIb devices (according to UKCA / MDR). The role will be a mixture of remote working as well as office based when needed. Responsibilities will include:
- Creating a QMS for a new established company according to ISO 13485
- Managing the Quality Management system day to day.
- Creating technical files for products Class I, Class IIa, Class IIb according to MDR/ UKCA
- Liaising with overseas manufacturers / contractors to ensure compliance.
- Carry out and assist with audits throughout the business
- Ensure procedures are in place and associated documentation is correct.
- Oversee the implementation of an Electronics document management system.