Consultant: Stewart McGrath
Salary: £30000 - £35000
Job Status: Permanent / Full Time
KEY PURPOSE OF ROLE:
- Management of NPI projects. Ensuring continued regulatory clearance of the existing product portfolio.
RESPONSIBILITIES OF THE ROLE:
- The management of new product development projects from concept to launch.
- Planning and co-ordination of workload and resources to meet business goals.
- Tracking and reporting project progress and plans.
- Tracking and forecasting project expenditure.
- Liaison with other staff.
- Liaison with customers and suppliers.
- Ensuring appropriate project documentation is prepared and approved as required by the QMS.
- Maintaining and developing the department’s part of the QMS
- Regularly reviewing the documents and data that support our existing portfolio of products against current requirements.
Where gaps are identified, taking action to get the gaps closed.
- Regularly reviewing the Procedures, SOPs and Documents that are owned by or followed by the Department against current Regulatory and Company requirements. Where gaps are identified, taking action to get the gaps closed.
- Managing CAPA as assigned.
- Training of other staff as required to maintain compliance.
- Management of assigned Changes within the Company’s Change Management system
- Giving support to OEMs on their existing products, e.g. management of Purchasing Specifications, the provision of supporting evidence and answering technical queries.
- Supporting Registrations with the provision of supporting evidence etc.
- Representing the Design function at Regulatory Inspections and Audits.
- Giving technical support on our products to other functions e.g. Quality, Sales.
- Maintaining and developing the department’s Databases and extracting data as required.
- All the above to be done in accordance with the requirements of MDD 93/42/EEC , CFR820 and ISO 13485
QUALIFICATIONS AND EXPERIENCE:
- Education: PhD, BSc, HND, HNC or equivalent in a medical, mechanical or other relevant engineering discipline.
- Experience: a minimum of two years private sector experience in a similar role involving manufacturing medical devices.
- Technical Skills: Sound engineering knowledge. Knowledge of manufacturing within the requirements of the medical regulatory framework.
- Computer skills: Conversant with MS Office including Access, MS Project or equivalent and Solidworks or other CAD.
- Personal attributes: Good organisational, analytical and communication skills, good attention to detail.
You will be working alongside the fastest growing recruitment company in the UK, who provide an unrivalled service to all of their clients and candidates across the United Kingdom. Seven currently offer the best contractor pay rates in the UK for Life Sciences, making us the best option for maximising your earning potential and career fulfilment. Seven Consultants are passionate about placing you in the best possible role, for the best possible rate, while providing a support platform, which is accessible around the clock.
Are you ready for the challenge? If so, we look forward to hearing from you.
What else can you expect from Seven?
– Specialist Consultant allocated to you with all the expertise you require.
– Excellent Payroll and Compliance System, ensuring that you are paid on time, every time.
– Access to Exclusive Rates, allowing you to gain earnings that no other agency can offer you.
– £250 Referral Bonus for every person you successfully refer to Seven.
If you are interested in this opportunity, please call 020 3887 7365. Please ask for Stewart McGrath in the Life Sciences team.