Quality Engineer (Medical Devices)
- Contract Type
I am currently working with a Medical Device and IVD Company based in Hampshire who are looking for a QARA Specialist to join their team as the company expands.
The salary will be between £40,000 and £45,000 depending on experience.
The QARA Specialist will be responsible for:
- The upkeep and improvement of the Company’s quality systems and processes so that the Company meets Quality and Regulatory compliance.
- To maintain the Quality Policy for the Group for the benefit of its customers, suppliers and employees.
- To make recommendations for corrective action necessary to ensure conformity with quality legislation and specifications
Main duties and responsibilities
- The upkeep and further improvement of the Quality Systems and processes to ensure optimum compliance with relevant corporate and regulatory policies.
- Support the Sr QA/RA Manager in maintaining a QMS that meets the applicable regulatory and company requirements including ISO 13485/9001/EC certification.
- Assist in the creation of standard operating procedures and policy guidelines
- Consulting company personnel in achieving and maintaining regulatory conformity as a prerequisite to worldwide market access of IVD products
- Supporting the Sr QA/RA Manager with post-market regulatory compliance / surveillance activities for EU and International product approvals.
- Assist with customer complaints
- Assist with regulatory issues such as recalls or field safety corrective actions and advisory notices
- Perform internal audits as required
- Perform other duties as required or assigned by the Sr QA/RA Manager
Qualifications and experience required
- Previous experience in successfully managing design projects for complex IVD devices
- Ideally educated with a bachelor’s degree or HNC in a relevant scientific discipline
- Strong regulatory background within the IVD industry is essential
- Experience with ISO 13485, ISO 9001 and EC certification
- Experience in international medical device regulatory submission/approval preferred.
- Auditing skills - Internal Auditor to ISO 13485/9001 is desirable
- Knowledge of GHTF STED, and IVD CTS documentation requirements
- Strong team player providing support, guidance and expertise in achieving regulatory compliance and customer satisfaction by educating, analysing and facilitating improvements through interaction with both internal and external customers
- Root cause analysis techniques, FMEA and risk analysis techniques.
- Knowledge of Design control, Risk Management, Product Development processes and Batch Release.
- Experience with New Product Introduction and R&D team to lead regulatory input in R&D project.
If this is something that either you or someone you know, has the required experience and is interested, then please do apply online with a copy of your most recent CV and give Jack Lundgren a call on 0207 812 7700.