Company: X4 Group
Location: West Yorkshire
Closing Date: 03 Feb 17
Salary (£): 30,000 - 40,000
QA Engineer/ Quality Engineer Position: QA EngineerLocation: West YorkshireSalary: DOEA Medical Device company based in West Yorkshire are currently looking for a QA Engineer to join the team on a permanent basis.The Quality Engineer will lead on all quality related aspects of multiple projects and ensure key aspects are delivered to meet project deadlines. ...
QA Engineer/ Quality Engineer
Position: QA Engineer
Location: West Yorkshire
A Medical Device company based in West Yorkshire are currently looking for a QA Engineer to join the team on a permanent basis.
The Quality Engineer will lead on all quality related aspects of multiple projects and ensure key aspects are delivered to meet project deadlines. The role will involve working with design teams throughout the design process to ensure that requirements of current standards and regulatory requirements are being met.
QA Engineer Role and Responsibilities:
- Collaborate with design project team members to achieve key deliverables to meet project deadlines.
- To identify, lead and plan on quality related project deliverables
- Work with the project teams to plan and organise quality related deliverables and requirements
- Participate and lead in project risk analysis (e.g., establishing risk documents such as FMEA)
- Work with project teams to select and evaluate suppliers during the design phase
- To carry out supplier audits as required during the design phase
- Work with project teams to identify and carry out design and process validations during the design process, including the design transfer stages (IQ/OQ/PQ)
- Guide and advise the design team on quality related design requirements with respect to relevant standards and regulatory requirements
- Review/ carry out gap analysis of existing DHFs/Technical Files to identify testing requirements to comply with current standards
- Identify and plan testing strategies for various quality related requirements
- Write technical justifications and validation reports
- Write/collaborate in writing clinical evaluations to meet current regulatory requirements
- Managing customer complaints from receipt to closure
- Developing, improving and writing new processes and SOPs as required
- Participating in NCR/CAPA reporting and investigations
- Managing calibration schedules and liaising with other departments to ensure all equipment is calibrated
- Routine environmental monitoring of the clean rooms
- Internal quality compliance audits
QA Engineer Candidate Requirements:
- Effective communicator with good interpersonal skills
- Internal and external customer oriented/focused and able to develop and maintain good customer relationships
- Well organised and able to manage documentation
- Plans, schedules, and completes tasks/projects to meet deadlines and corporate objectives
- Is a team player and able to work in a cross-functional team
- Commercially aware
- Knowledge/understanding of FDA regulations (including 21CFR 820), EU Medical Device Directives and Canadian Medical Device Regulations required.
- Knowledge of the requirements for international quality systems, including ISO 13485:2012, 9001:2008 required.
- Must have clean room and sterilization knowledge including knowledge of standards relating to cleaning and sterilisation of medical devices.
- At least 2 years relevant experience in a similar role in the Medical Devices Industry
- Minimum HND/Bachelor’s Degree required, preferably in a Science or Engineering field.
- Lead auditor in 9001:2008/13485:2012
Apply by sending your updated CV through to email@example.com and call Laura on 0207 812 7700 to discuss your application in further detail. Interviews are available for next week.
Medical/ Medical Devices / Quality / Regulatory / ISO 13485 / CAPA / Audit / QMS / Systems / QC / SOP / Validation / Protocols