Compliance and Quality Assurance Manager
Our trailblazing global AAC (Augmentative and Alternative Communication) company, is on the lookout for an exceptional Compliance and Quality Assurance Manager to join our product development team and report to the Head of Hardware. At Smartbox, our cutting-edge technology gives a voice to those with limited speech, positively impacting the lives of people with disabilities worldwide. As a Compliance and Quality Assurance Manager, you will be a driving force for quality in the development team. You will upgrade our team, systems and processes using innovative methodologies.
Your expertise in product compliance or regulatory affairs will be key to our continued success. All around the world, our products, accomplishments and aspirations are a reflection of our teams' values: passionate, caring, empowering, achieving together and enabling change.
This is a hybrid role based in Bristol, with the requirement to come into the office twice a week. The salary for this position will be determined based on the applicant's education, skills and experience.
How will you be making a difference
- Regulatory Compliance: Ensure that all products comply with local, national, and international regulations, including CE, MDR, FDA, FCC, RoHS, REACH, and other industry-specific standards.
- Documentation and Certification: Prepare and maintain all necessary documentation for product compliance, including test reports, declarations of conformity, and technical files. Liaise with third-party certification bodies as needed.
- Risk Management: Identify potential compliance risks throughout the product lifecycle and develop strategies to mitigate these risks.
- Testing and Validation: Oversee and coordinate product testing to ensure compliance with applicable standards. Work closely with internal and external laboratories to validate test results.
- Cross-functional Collaboration: Collaborate with engineering, design, manufacturing, and legal teams to integrate compliance requirements into product development and manufacturing processes.
- Standards Development and Monitoring: Stay updated on changes to relevant regulations and standards. Participate in industry forums and standards development organisations.
- Training and Guidance: Provide compliance training and guidance to internal teams, ensuring that all stakeholders understand and adhere to regulatory requirements.
- Continuous Improvement: Lead initiatives to continuously improve compliance processes and systems within the organisation.
Essential Qualifications/skills/experience
- Technical Proficiency in Electrical Safety, EMC, and Environmental.
- Degree or equivalent experience in an engineering discipline.
- 4+ years' experience in product compliance or regulatory affairs.
- A creative entrepreneurial attitude.
- Infusing enthusiasm and a positive attitude into your work.
- Expertise in Regulatory Process.
- Proficiency in Quality Management Systems.
- Effective Communication at All Levels: Demonstrating the ability to communicate clearly and persuasively across various organisational levels, facilitating effective collaboration and understanding.
- 8D/CAPA.
- High Level of Technical Skills.
- Analytical Thinker: Demonstrating strong analytical thinking capabilities, enabling the navigation of complex risk determinations and the formulation of informed decisions based on critical analysis.
- Attention to Detail: Displaying a keen eye for detail and meticulousness in work, ensuring accuracy and precision in tasks and deliverables.
- Self-Starter.
- Excellent Collaborative Skills.
- Meticulous Organisation.
- Strong Project Management Skills: Possessing the ability to manage multiple projects simultaneously, ensuring timely delivery, effective resource allocation, and successful project outcomes.
- Global Perspective.
Useful Qualifications/skills/experience
- Experience in a medical device company
- ISO 9001
- ISO 13485
- ISO 60601-1
- ISO 14971
- EU MDR
- FDA Medical Devices
Why join us
Here at Smartbox, we are positive and inclusive about making adjustments, providing flexible working, and encouraging all staff to engage in a diverse range of year-round learning and personal development opportunities. In addition, you will work alongside highly motivated colleagues in an environment of strong teamwork whilst also having fun. This is a hugely rewarding role and a career to be proud of where every day you will go home knowing you made a positive difference in the lives of disabled people.
Rewards and benefits
At Smartbox our employees always do their best, which is why we give so much in return. In addition to your competitive salary, private medical insurance, and a whooping 25 days of holiday plus public holidays, we'll shower you with perks, including:
- Dress
: We want you to feel comfortable in the office; smart casual is perfect.
- Food
: You can find free healthy office snacks in our kitchens.
- Hybrid working
: Laptop and home working IT kit provided.
- Flexible work schedule
: Balance is key to innovation, and we want to make sure you are at the top of your game with a schedule that will work for you (prior agreement from your line manager is required).
- Give back to the community
: Each year every member of staff will get the opportunity to spend one paid day volunteering for a good cause of their choice.
- You, our best asset
: We believe in investing in you and your development. Stay with us and grow with us! We will reward you with more holidays for your long service!
- Wellness
: Stretch away the stress every morning with our online trainers, available via our cooperative perk website or hit the gym. We provide gym discounts too!
- Wellbeing
: You gain unlimited access to a benefit and Wellbeing app Yulife,providing store discounts and wellbeing services.
Mental health
: You will have access to the 24/7 Employee Assistance Programme for a wide range of support, advice and resources about Family, Health, Life, Money