Regulatory Associate required for exciting new opportunity with medical device company in Central Belt of Scotland.Are you a science graduate with regulatory experience?Are you looking...
Quality Specialist / Engineer - Permanent - Central Belt of Scotland
Are you an experienced Quality Engineer/Specialist based in Central Scotland looking for a new challenge?
Do you have experience in a medical device manufacturing environment?
SRG is recruiting for a Quality Engineer for a young and dynamic life science organisation based in Central Scotland.
This is an exciting opportunity for a Quality Engineer/Specialist to join the Quality team at my clients new facility in Central Scotland to be responsible for the development of quality activities associated with product development through the R&D and the verification and validation phases.
- Quality representative for project teams throughout product lifecycle and product realization activities.
- Creation and management of documentation forming the Design History File and Device Master Record.
- Assess, control and coordinate changes to Design History File and Device Master Record.
- Coach and support in the writing of design requirements and specifications as well as Verification and Validation plans and protocols.
- Creation and management of traceability matrices, prepare and create documents and records.
- Organize, host and facilitate risk management related activities and design reviews with the project teams and ensure compliance of such activities to the applicable standards and regulations.
- Ensure compliance of documentation for design partners (and suppliers) within the supply chain.
- Support clinical processes for assays in development.
- Review and approve as Quality representative on project teams and QMS and for Device History Records and final product release.
- Support the QMS day to day activities, such as CAPA, Change Control, Supplier management, complaints investigation, audits and other routine quality activities.
Qualification, Skills & Experience required:
- The successful candidate for this role will have a scientific background with previous experience in a similar quality focussed role within the Medical Devices industry, working to ISO13485 and 21 CFR Part 820.
- You must have experience in development, verification and validation and post launch activities within a medical device environment.
- You must have excellent organisational and communication skills, with demonstrable problem solving ability and be a strong influencer.
If you are looking for a challenging new role and want to work for a rapidly expanding life science company based in Central Scotland then this position is for you.
SRG is the UK's number one recruitment company specialising in the scientific, engineering, clinical, pharmaceutical, food/FMCG, energy & renewables, biotech, chemical and medical device sectors.
As scientists ourselves, our specialist sector knowledge and our passion are second to none. It's this combination that makes us different. We're committed to providing excellent temporary, contract and permanent career opportunities of all levels for our candidates and a comprehensive range of expert strategic recruitment services for our clients.
If you would like to apply for this position, please use the link provided.
For more information regarding this position or any others, please contact Pamela.
If you have a scientific background and this position is not relevant / suitable for you please feel free to get in touch or visit www.srg.co.uk to view our other vacancies.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, ethnicity, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Keywords: quality, QA, medical device, ISO13485, FDA, product development, diagnostics, design review, design history file, validation and verification
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.