Quality Engineer
- Recruiter
- Fish4Jobs
- Location
- Hertford, Hertfordshire
- Salary
- salary 27,000
- Posted
- 16 Aug 2017
- Closes
- 01 Sep 2017
- Ref
- qe/st
- Sectors
- Engineering
- Contract Type
- Permanent
- Hours
- Full Time
Quality Engineer
salary for the role is circa £27,000
Monday to Friday (40hrs pw).
Bishops Stortford
Function: To strengthen the technical and quality management resource. Working as a key member of the team supporting design and development operations whilst developing and improving the existing quality systems to meet future requirements. To develop the existing ISO 9001 and 13485 quality system, ensuring full adherence to the quality programmes.
INITIAL DUTIES
·Maintaining technical files for Class 1 and II products
·Maintenance of records and quality documentation
·Change control
·Assist in conducting Validations
·Conducting FMEAs and assisting in Risk Assessments
·Assist in design transfer process
·Support developing packaging and labelling artwork in compliance with regulatory requirements and controlling labelling and artwork process
·To contribute to new product development and improvement of existing systems
·Assist in third party and NB audits
·Oversee document translations as per the regulatory requirements
·Assist in regulatory certifications as well as UL and RoHS compliance
·Flexibility: any other duties that may be requested from time to time to ensure the smooth running of the company.
KNOWLEDGE AND SKILL REQUIREMENTS
·Familiar with ISO 9001, ISO 13485 and MDD
·Experience in product registration for Class I and Class II b medical devices
·Experience in generating DHF and Tech Files
·Regulatory knowledge (including RoHS)
·Knowledge of CHP-CLP preferable
·Computer skills
·Organisational and co-ordination skills
·Ability to work alone and within a team
·Good communication skills
·Reliable & diligent team member
·Numerate and literate
·Ability to work under pressure and to timescales