Medical Device QA Specialist
MEDICAL DEVICE QA SPECIALIST
Reporting to the QA/RA Manager, you will be responsible for ensuring continued compliance and improvement of the Quality Management System of the company with the relevant European Medical Device Regulatory requirements, and to ensure that these are continually maintained and implemented in the best way possible. You will be expected to work independently and be accountable to deliver against agreed deliverables in a fast-paced small business environment and have the opportunity to innovate and contribute as part of a small QA/RA team, working closely with the QA/RA Manager and an RA Specialist. This full time and office based position is suitable for an individual who is a self-starter, passionate about quality and can immediately add value to the organisation.
- Provide day-to-day support and be responsible to maintain the effectiveness of the quality management system, including document control, CAPA, Vigilance, Risk management, internal audit, post-market surveillance, supplier monitoring and assessment and product release activities
- Contribute to strategic improvement projects to improve business processes and the implementation of MDR (EU) 2017/745
- Prepare and present quality data to analyse quality trends and support investigations, remediation and improvement initiatives
- Highly accurate, with meticulous attention to detail. Right first-time mentality
- Intermediate level of Technical competence in the interpretation and methodology required to interpret ISO 13485 requirements in relation to Class I and Class II medical devices
- Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment.
- Show a mindset and behaviour appropriate to a quality ambassador for the company setting the best example to other employees and external regulators and customers
- Be intellectually curious and self-motivated to drive self-learning and utilise mentoring opportunities within the company
- Proactive mentality within the workplace to drive solutions orientated outcomes in collaboration with other team members
- Ability to work in collaborative and independent work situations
- Ability to remain calm and receptive in fast paced situations
- Having an open mind, ready to learn and improve
Skills & experience
- Knowledge and/ or experience of both ISO 13485 & European medical device requirements (MDD 93/42/EEC and MDR (EU) 2017/745) is mandatory
- Knowledge of quality management systems and associated documentation
- Bachelor's degree or equivalent in a related field
- At least 2 years' experience working in a regulated medical device manufacturing environment
- Be aware of the latest medical device regulations and standards. Knowledge of Microsoft Office including Excel, with an ability and experience performing intermediate level data analysis
Medicareplus International is part of the Chemilines Group of companies. It is a fast growing market innovator in the research, manufacture and distribution of cost effective, clinically proven protective and regenerative healthcare products that maintains skin integrity. We are located in Wembley, London and offer free onsite parking. The nearest Tube stations include, Alperton, Hanger Lane and Perivale (Piccadilly & Central Lines).
What we offer
- SME company with plenty of opportunities to grow and shine.
- Competitive salary, immediate start.
- 23 days holiday plus statutory 8 bank holidays.
- Auto enrolment into pension scheme.
- Free car parking on site.
- Staff discount on certain products...... click apply for full job details