Job Title: Quality Engineer
Department: UK Operations
COVVI have taken the upper limb prosthetic market by storm, introducing the Nexus multi-articulated hand. A ground-breaking medical product offering a new level of quality and performance that utilises premium materials and cutting-edge technology and has the propensity to change many lives forever.
An opportunity has arisen to join our hard-working team as a Quality Engineer, to work alongside Production and Operations by ensuring the parts coming in and finished goods going out are to the highest standard. We are at an exciting point in the business with an exciting pipeline set for 2022 so the potential for the role, and you, to grow is massive.
PURPOSE AND SCOPE
COVVI aims to deliver the highest quality product, backed with the highest quality customer service, including rapid delivery and repair of medical devices to a worldwide customer base. To do this we are looking to add to the Quality department and work towards a flexible, but sustainable Quality Management System. The right candidate needs to be able to conduct incoming component and outgoing Pre-Delivery Inspections, with the opportunity to contribute to Quality on a company-wide basis. Quality begins the moment you step through the door and the right attitude is every bit as important as the skillset.
- Incoming component inspections including:
- Understanding technical drawings
- Use of the Keyence Inspection machine
- Pre-Delivery Inspections of Finished Goods
- Sub-assembly inspections
- Follow-up non-conformances with Suppliers, Production, Engineering
- Maintaining Quarantine
- Accurate Record maintenance
- Delivering ideas/solutions to improved testing
- Contributing to quality systems in compliance with ISO 13485 and FDA 21 CFR 820
- Schedule and monitor internal and external audit programme in accordance with external certification requirements
- Contribute the COVVI SQA (Supplier Quality Assurance) programme
- Direct reports: No direct reporting initially.
- Internal: Group board, production, engineering, purchasing, and quality control.
- External: Customers, suppliers, and the general public.
EDUCATION, EXPERIENCE AND TRAINING
- Experience (1 year minimum) in a Quality based role under ISO 13485 in a relevant industry
- Educated to a minimum HNC or HND level although degree level (in an engineering discipline) is preferable
- Experience of working within a fast-paced environment
- Detailed knowledge of component measurement techniques
- Written and oral communication skills appropriate for dealing with technical, operational, and commercial issues with customers/suppliers
- Experience as an Auditor (beneficial, not essential)
- Fast learner, capable of understanding a range of products within the prosthetics market
- Excellent problem-solving skills
- Strong organisational skills
- Good understanding of manufacturing techniques
- Excellent project, planning, change, and time management capabilities
- 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
COVVI Limited operates a direct sourcing model for our recruitment needs and therefore do not accept uninvited approaches from Recruitment Agencies.
Any unsolicited CVs received by COVVI Limited will be treated as the property of COVVI Limited and any terms and conditions associated with the use of such CVs are considered null and void. We retain the right to pursue and hire that candidate without any obligation to third party terms and conditions, regardless of their inclusion in any email or supporting documents (including CVs).