Quality Assurance Officer
5 days ago
**Job Summary** - Quality Assurance Officer
**Introduction**:
An opportunity has arisen to join our hard-working team as a Quality Assurance Officer. You will work closely with R&D, Production, Customer Service and Finance teams to ensure quality compliance in all areas of the business. We are at an exciting point in the business with an exhilarating pipeline set for the next 12 months so the potential for the role, and you, to develop is significant.
**Purpose and Scope**:
**Responsibilities**:
- Implementation of ISO 13485, ISO 9001 and FDA 21 CFR 820 including registration, upkeep, control, and improvements
- Update SOPs and Compliance documentation in line with regulatory requirements and updates
- Schedule and lead internal and external audit programme in accordance with external certification requirements
- Lead Supplier Audit programme
- Deliver company-wide training on SOPs
- Manage company metrology equipment
- Follow-up non-conformances with Suppliers, Production, Engineering
- Effective CAPA management
- Cover for Quality Control where required
- Accurate Record maintenance and associated reporting to management on KPI’s
- Ensure all new products are developed in line with relevant external safety, regulatory and quality standards
- Ensure Quality Assurance in USA Office, and future satellite repair facilities
- Create a positive Quality culture within COVVI
**Organisation Relationships**:
- **Direct reports**: No direct reporting initially
- **Internal**: Senior Management Team, Production, R&D Engineers, Supply Chain Manager, Customer Services and Finance.
- **External**: Customers, Suppliers, Regulatory Bodies
**Education, Experience and Training**:
- Experience (5 year minimum) in a Quality based role under ISO 13485 in a comparable industry
- QA and QC experience in a highly regulated environment.
- Educated to a minimum HNC or HND level although degree level (in an engineering or similar discipline) is preferable
- Experience of working within a fast-paced environment
- Detailed knowledge of component/gear measurement techniques
- Written and oral communication skills appropriate for dealing with technical, operational, and commercial issues with stakeholders across the business
- Experience in leading Quality Audits in line with relevant standards (ISO 9001, ISO 13485)
- Full driving licence
**Technical Skills**:
- Fast learner, capable of understanding a range of products within the prosthetics market
- Excellent problem-solving skills
- Strong organisational skills
- Comprehensive knowledge of quality assurance principles and methods
- Comprehensive knowledge of manufacturing techniques
- Excellent project, planning, change, and time management capabilities
**Behavioural Characteristics**:
- Passionate about Quality and Precision
- A willingness to stand firm on decisions
- Committed to delivering objectives in line with the COVVI vision.
- Positive engagement including strong two-way communication with patients, customers, colleagues, and suppliers
- Problem-solving and a solutions-oriented mindset
- A desire to develop professionally and contribute to business development
- Happy to help others and be proud to be part of, and help strengthen, the COVVI team
- Have integrity, honesty, and loyalty
**Job Types**: Full-time, Permanent
**Salary**: £38,000.00-£42,000.00 per year
**Benefits**:
- Casual dress
- Cycle to work scheme
- Free parking
- On-site parking
- Sick pay
Schedule:
- Monday to Friday
Ability to commute/relocate:
- Leeds, LS10 1DJ: reliably commute or plan to relocate before starting work (required)
Work Location: One location
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