iSMART Developments
Quality Manager
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Location: Remote, UK-based, with attendance in person at design reviews, programme gates and partner sites
Department: Quality and Regulatory
Travel: UK and international, as programmes require
Position Type: Full-Time
About Us
iSMART develops and manufactures advanced LED phototherapy devices for the world's leading beauty, dermatology and medical brands. We hold an FDA clearance on a five-wavelength light protocol, an international patent estate in stretchable printed electronics, and partnerships including L'Oréal Groupe. Our engineering, industrial design and intellectual property are held in-house, and we work alongside the engineering teams at our manufacturing partners to take products from concept to global launch across skincare, longevity, wellness and healthcare.
Our Advantage
- Regulatory Leadership: MDSAP ISO 13485 certified, FDA & MDR approvals across global markets
- Clinical Heritage: Devices validated through independent studies & peer-reviewed studies
- Proven Science: Optimised wavelengths with robust efficacy data
- Medical Applications: Acne, wrinkles, pigmentation, pain, wound healing, dermatitis & ongoing trials
- Manufacturing Excellence: We partner with MDSAP-regulated manufacturers, ensuring every device meets the highest global standards of safety, quality, and compliance.
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Quality Manager - Key Responsibilities
Quality Management System (QMS) Oversight
- Develop, implement, and maintain a compliant QMS (e.g., ISO 13485).
- Ensure the system aligns with regulatory requirements (e.g., FDA 21 CFR Part 820).
- Lead internal and external audits to ensure QMS effectiveness.
CAPA (Corrective and Preventive Actions)
- Lead investigation of non-conformities or product complaints.
- Root cause analysis and implementation of effective corrective actions.
- Monitor effectiveness of CAPAs and document outcomes.
Document and Change Control
- Maintain control over all quality documents (procedures, specifications, records).
- Oversee document approval processes and change management.
Training and Development
- Ensure that employees are trained on quality procedures and regulatory requirements.
- Maintain training records and monitor compliance.
Product Release and Batch Record Review
- Approve product release for market by verifying compliance to specs and batch records.
- Oversee lot release procedures in coordination with production and regulatory teams.
Complaint Handling and Post-Market Surveillance
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- Ensure complaints are reviewed, investigated, and closed appropriately.
- Manage field actions such as recalls or safety notifications if required.
- Trend analysis on complaints received
Continuous Improvement
- Drive quality improvement initiatives across departments.
- Analyze trends in quality data to reduce defects and increase reliability.
Governance
- Act as the Management Representative, reporting QMS performance and compliance to top management.
- Plan, coordinate and document Management Reviews and monitor resulting actions.
Preferred Skills
- Clearly communicate project status, quality risks, dependencies and mitigation plans to project teams and senior management.
- Develop strong working relationships with internal departments, external suppliers and customer stakeholders.
- Strong commercial acumen, able to balance business objectives with quality and regulatory requirements while supporting successful project delivery.
- Excellent project management and organisational skills with the ability to manage multiple priorities simultaneously.
What We Offer
- Competitive salary and performance-based bonuses.
- Opportunities for professional development and continuous learning.
- Workplace pension and life assurance.
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