Sector: Life Sciences
Consultant: Harvey Havell
Salary: £23000 - £26000
Job Status: Permanent / Full Time
QA/QC Regulatory and Compliance Executive
Location: London, NW2
Role : Permanent
Hours : Monday – Friday 9am – 5pm
Start date: ASAP
Salary: Up to £26k depending on experience
The Company was founded in 2002 to develop, manufacture and distribute medical supplies (consumables and equipment) • precision instrument production • quality clinical governance • excellent customer service • competitive pricing • fast efficient delivery to GPs, Clinics, Hospitals (Private and NHS)
Today they are recognised as a leading UK supplier and manufacturer of medical supplies and care products supplying over 10,000 products and manufacturing 700+ own label lines.
Reporting to Head of QA/ QC Department and Senior Management
- To support and work in the QA / QC Team and alongside the COO and the Head of Quality Assurance to ensure that the company’s manufacturing and distribution operations are fully compliant with all relevant Medical Device Regulations for medical devices; as well as taking an active part in audits, both internal and external.
- To support and work in the QA / QC Team for new product development/projects and maintain existing products; with reference to applicable standards and regulations.
Quality Control and Quality Assurance
- Work on new product development, sample review, product evaluation and prepare technical documents.
- Create, update and maintain technical files for medical devices.
- Prepare technical specification, datasheets and conformity certificate. Reporting and reviewing non-conforming products.
- Keep accurate and up-to-date record as such the documents are legible, traceable and retainable.
- Liaise with suppliers in relation to ensuring their operations are fully compliant with the company`s policies and relevant medical device regulations.
- Address/resolve CAPA, goods inspection, traceability and system records.
- Work with external consultant to ensure the company is informed of new regulation and ensure that the company`s policies always reflect such updates.
- Deal with faulty product, customer complaint and management of process.
- Communicate/vigilance reporting to notified body and competent authority in relation to medical device matters.
- Manage the supplier evaluation and approval processes, maintenance of approved supplier list, monitor their on-going performance.
- Verify labels as per 15223-1 and 21 CFR 801.
- Participate in internal and external audits.
- Quality assurance of sterile and non-sterile medical devices.
- Ensure we are compliant with Labour Standards Assurance System (LSAS) audit.
- Other duties as assigned by senior managements and head of the QC department
Preferred but not essential:
- Knowledge and/or experience of FDA regulation.
Experience and Education required
- Experience of similar role at pharma or medical devices manufacturing company.
- Outstanding supervisory experience.
- Excellent written and verbal English skills.
- Numerate with excellent attention to detail.
- Good data input skills.
- Competent IT capabilities (Excel and Word) and Outlook.
- Ideally a graduate, but minimum education to A level and above.
- Ability to direct and actively working to attain and ensure highest level of internal and external compliance and legal requirements.
- Excellent communication and service skills as role requires regular contact with internal teams, suppliers, clients and manufacturers, subcontractors and dealing with queries and resolving disputes.
- Self-motivated, flexible, able to multi-task, good organizational and time management skills, ability to priorities and manage workloads.
- Ability to work confidently, remain calm under pressure, meet deadlines and work in a team environment.
- Demonstration of positive team player spirit and cooperative sales skills.
- Committed, punctual and reliable.
- Attention to details.
- Pension Scheme
- On Site Parking
- Excellent working environment/brand new offices
- Accessible and supportive management
If you are interested in this opportunity, please call 020 3887 7365. Please ask for Harvey Havell in the Life Sciences team