Quality Assurance Engineer
Job Title: Quality Assurance Engineer
Department: UK Operations
Reports To: Chief Technical Officer
COVVI are made up of a highly innovative and dynamic engineering team who have set out to design and build a world-leading, highly functional bionic hand. We plan to change the global market and therefore need a world-class team to make this happen. We believe we have created a ground-breaking medical product that offering a new level of quality and performance that utilises premium materials and cutting-edge technology and has the propensity to change the lives of many forever.
PURPOSE AND SCOPE
COVVI aims to deliver world-class customer service and rapid delivery and repair of custom medical devices to a worldwide customer base. As such, manufacturing medical devices requires the rigorous maintenance of safety protocols and a general high quality has to be ingrained in everything we do.
- Lead quality systems in compliance to ISO9001, ISO 13485 ISO27001 and FDA 21 CFR 820, including registration, maintenance, control, and improvements.
- Implement systems which ensure every product is to the correct quality standard.
- Manage company metrology, ensuring COVVI have the capability to validate the quality of parts delivered and products produced.
- Report on & ensure KPI’s are met across the quality control process.
- Ensure all new projects are successfully launched within the physical and technical documented requirements of MDD 93/42/EEC, FDA 21 CFR 820 and ISO9001:2008, and other external standards as required, (i.e. FCC/IC, EMC and safety testing).
- Schedule and monitor internal and external audit programme in accordance with external certification requirements.
- Lead 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
- Proven experience (5 years minimum) in a quality or process engineering role in a relevant industry.
- Educated to a minimum HNC or HND level although degree level (in an engineering discipline) is preferable.
- Experience as an ISO9001 Lead Auditor, and with ISO13485.
- 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.
- Full driving licence.
- 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.
- 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.
- Passionate about quality and precision.
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)