Senior Quality Engineer
IQ Endoscopes Ltd. Chepstow
The opportunity
IQ Endoscopes is seeking a Senior Quality Engineer from the medical device engineering or manufacturing space. This role exists to ensure the highest standards of quality and compliance in the development and manufacturing of endoscopic medical devices.
This role includes driving risk management activities, supporting design and development processes, and overseeing sterilisation validation to ensure product safety and effectiveness. Through root cause analysis and continuous improvement initiatives, the Senior Quality Engineer collaborates with cross-functional teams to deliver high-quality, safe, and compliant endoscopic devices that meet industry standards and enhance patient outcomes and leads by example acting as a natural ambassador for quality and compliance across departments.Your main focus will be
- Directly support with Design and Development (Design Control) of new and existing product portfolios for intended target markets as applicable, predominantly, UK, EU, US and Australia
- Lead, generate and maintain the Risk Management in accordance with ISO 14971 for all products in IQE’s portfolio
- Support sterilisation validation and requalification activities in collaboration with relevant teams and third-party organisations
- Support non-conformance, complaints, change control and market feedback process in conjunction with Compliance
- Support Design Transfer activities
- Support Quality, Regulatory and Clinical function as needed
- At least 4 years of experience in a similar role the majority of which needs to be within medical device environments
- A minimum degree level or equivalent qualification in a relevant medical science, science or engineering discipline, preferably biomedical or bioscience
- Experience of working fully in line with ISO 13485, ISO 14971, UK MDR, and US FDA 21 CFR Part 820
- Experience working within Design Control frameworks, i.e. 21 CFR Part 820.30 and ISO 13485 Clause 7.3
- Experience within a manufacturing environment of at least EU Class IIa devices
- Authorisation to work in the UK. We are unable to provide sponsorship at this time
Essential to your application is quality engineering experience within medical device industry.
Culture of IQ Endoscopes
We have a product with the capacity to genuinely change lives for the better and bring huge benefits to the medical device industry and industry professionals, and we want our new colleagues to feel as passionate about our mission as we are.At IQ Endoscopes, culture is incredibly important to us, and we recruit colleagues who fit that culture. This isn’t just a job to us, it’s a passion.
We want you to be a part of our vision and to find your purpose within our organisation.
PURPOSE: To create pioneering endoscopy technologies for the early diagnosis of diseases, helping people live longer & betterVISION: A world where everyone has easy access to safe, sterile endoscopy
MISSION: Design and deploy high quality sustainable single use endoscopes
STRATEGY: To enter the single use endoscopy market as soon as possible with a product range that is clinically and commercially credible, will be adapted to meet future market demands and sets the benchmark for carbon neutral responsibilities
VALUES: We work together to achieve shared goals through our values…
PASSIONATE: We show our pride and enthusiasm
INNOVATIVE: We challenge, question and push past the status quo
EMPOWERED: We support our people to explore their own potential
INCLUSIVE: We understand the value of an alternative perspective
TRANSPARENT: We are open to our people, sharing information and knowledge
Equity, Diversity and Inclusion at IQ Endoscopes
At IQ Endoscopes we work hard, but we give ourselves a break. We support each other, but we question and challenge each other’s thinking. We recruit highly skilled professionals and specialists, but we collaborate and listen to each other’s opinions and ideas.It doesn’t matter where you come from, what your background or beliefs are, who you love or how you express yourself. What matters is that you are you, and you can be you within our team. Our inclusive culture has grown organically as a result of focusing on recruiting the right person with the right skills.
Nothing else. Plain and simple.
We welcome applications from the neuro enlightened community. Talk to us if you have any ideas about how we can improve our recruitment process. We want to know! hr@iqendoscopes.co.uk.What we will give you
- Competitive salary to fit this level of position
- Hybrid working fixed and 2 days on site Tuesday and Wednesday with Thursday depending on business needs
- 25 days annual leave plus bank holidays
- 2 additional paid ‘Disconnect Days’ following probation
- 2 additional days paid dependents leave & paid compassionate leave: entitlement from day 1
- Enhanced pension 5% paid by employer & 3% employee
- Refer a friend bonus
- £100 equipment allowance
- Health Shield: an employee health & wellbeing platform encompassing & 24/7 EAP service
o GP Anytime: 24/7 access to a phone or chat based GP
o Face to face counselling: referral where required through EAP service
o Access to online health screening, physiotherapy & skin detectiono Employee PERKS & gym discount scheme
Job Types: Full-time, Permanent
Benefits:
- Additional leave
- Bereavement leave
- Casual dress
- Company events
- Company pension
- Employee discount
- Enhanced maternity leave
- Free parking
- Health & wellbeing programme
- On-site parking
- Sick pay
- Transport links
- Work from home
Schedule:
- Monday to Friday
- No weekends
Education:
- Bachelor's (required)
Experience:
- Medical Device Quality Engineering: 3 years (required)
- Senior Quality Engineering: 3 years (required)
- ISO 13485: 3 years (required)
- ISO 14971: 3 years (required)
- Medical Device Regulation: 3 years (required)
Work authorisation:
- United Kingdom (required)
Reference ID: IQE SQE 1411
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