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Quality Compliance Coordinator

7 months ago

Braintree, United Kingdom CARECO UK LTD Full time

Here at CareCo, we’re all about making life easier for people. It gets us out of bed in the morning, and it sends us home at the end of the day knowing we’ve done our bit to help somebody with their day-to-day struggles.

To support our recent growth and development, CareCo are seeking a Product Compliance Coordinator to join us in our Head Office in Great Notley, Braintree.

Reporting to our Head of Quality & Compliance, you will be assisting with the responsibilities for Planning, Managing, Monitoring and Reporting on the organisation’s product conformance of Medical & Non-Medical Device products.

**What are my responsibilities?**
- Review and evaluate the effectiveness of supplier testing information of new products to determine whether conformance to applicable ISO standards and UK regulatory & legal guidelines has been met.
- Maintain, monitor, and report on the conformance status of the product portfolio.
- Maintain, update, and manage the technical files for medical device products.
- Be a Point of Contact (PoC) for Product Conformance & Quality Assurance queries raised by the business.
- Support in the implementation of design changes for continual product improvement.
- Handle any Field Safety Notifications and/or product recalls.
- Draft technical bulletins for internal communication.
- Oversee Post Market Surveillance.
- Respond to government and industry related consultations - authorities such as BHTA, MHRA and Trading Standard Institute.
- Ensure of the maintenance for proposed changes to MDR (Medical Devices Regulations), Furniture and Furnishing Regulations and Trading Standards Institute pricing practices guide.
- Support & Deputise for the other Quality & Compliance team members when required.
- Revise current product labelling and packaging specifications in line with the aforementioned regulations and harmonisation with the company ERP system.
- To liaise with all domestic and overseas suppliers, ensuring they have a clear understanding of who is responsible for what.
- Provide feedback opportunities for product specification improvements as a result of the monitoring of their performance and any issues highlighted.
- Support the Compliance Manager to develop and implement due diligence procedures for new products and suppliers, ensuring they meet the requirements of the company in line with our terms and conditions prior to any purchase orders being raised.
- Adhere and implement all other consumer related law such as; Sale of Goods Act, Consumer Contract Regulations, Consumer Credit Act, Consumer Protection from Unfair Trading Regulations, Consumer Rights Act, General Data Protection Regulations.
- Play an active role in achieving the following accreditations: ISO 9001, ISO 14001, ISO 13485.
- Conduct departmental presentations and reports for the wider business.

**What is required of you?**
- Experience (2+ years) of working in a product conformance environment (i.e., product testing conforming to various ISO standards / other legal & regulatory requirements prior to UK sale).
- A good understanding of ISO 13485 (Medical Devices) management systems and awareness of Medical Device Regulations & requirements.
- Experience of working with ISO management systems.
- Ability to report and escalate regulatory & quality issues externally to regulatory bodies and to senior management internally.
- Ability to manage stakeholder expectations.
- Computer literate intermediate or advanced in Microsoft Office 365 packages.
- Hold a driving licence suitable for use in the UK.

**What skills do you need?**
- Confidence and interpersonal skills to engage at all levels.
- Compliance & customer focused with the ability to build positive working relationships.
- Flexible and adaptable; able to work in ambiguous situations.
- Resilient and tenacious with a tendency to persevere.
- Ability to work under pressure in a dynamic and changing environment.
- Organised with a natural inclination for planning.
- Problem solving and root cause identification skills.
- Innovative with a continuous improvement and change focus.

**What do CareCo offer you?**
- £35,000 to £40,000 per annum, dependent on experience
- 37.5-hour working week, Monday to Friday
- 30-days annual leave with extra days holiday for long-standing employees
- Excellent on-site facilities, including a subsidised cafeteria
- Access to our bespoke benefits programme for staff
- Loyalty & Celebration vouchers

**Job Types**: Full-time, Permanent

**Salary**: £35,000.00-£40,000.00 per year

**Benefits**:

- Canteen
- Casual dress
- Cycle to work scheme
- Discounted or free food
- Employee discount
- Enhanced maternity leave
- Enhanced paternity leave
- Free flu jabs
- Free parking
- Health & wellbeing programme
- On-site parking
- Referral programme

Schedule:

- 8 hour shift
- Monday to Friday
- No weekends

Ability to commute/relocate:

- Braintree: reliably commute or plan to relocate before starting work (required)

**Experience**:

-