Quality Manager

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.

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

• Ensure complaints are reviewed, investigated, and closed appropriately.
• Manage field actions such as recalls or safety notifications if required.
• Trend analysis on complaint 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.

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What We Offer

• Competitive salary and performance-based bonuses.
• Opportunities for professional development and continuous learning.
• Workplace pension and life assurance.