The individual is a proactive and highly skilled Technical Engineering Manager to lead technical operations within our Beauty, Aesthetic, and Medical Device divisions. Responsible for managing and enhancing specific functions within our Quality Management System (QMS), driving technical documentation, supplier performance, fault diagnostics, People Managemen t and leading change management initiatives. This role is pivotal in ensuring that products meet rigorous regulatory standards while supporting continuous technical and process improvement. In addition, performing necessary administrative duties as required and other duties as assigned. Finally, Initiating opportunities for continual improvement and interacting positively with other departments in the business.
Key Responsibilities:
1. Technical Management & Fault Finding
Oversee the resolution of technical issues across the product lifecycle, including diagnostics and root cause analysis of returned or faulty devices.
Lead investigations and implement corrective actions for product failures or customer complaints regarding device / component failure.
Liaise with service/repair teams and R&D to improve product reliability and reduce recurring faults.
2. Quality Management System (QMS)
Maintain and improve the QMS in compliance with ISO 13485, MDR, GMP, and other applicable regulations.
Conduct internal audits and coordinate external audits (e.g., notified bodies, regulatory agencies).
Lead CAPA activities and risk management reviews (FMEA, hazard analysis).
3. Technical Documentation
Develop and maintain essential technical documentation such as:
Work Instructions (WIs)
Test Instructions and Validation Protocols
Job Cards
Device History Records (DHRs)
Ensure documentation is aligned with design specifications, regulatory requirements, and production needs.
4. Supplier & Component Management
Qualify, audit, and monitor technical performance of suppliers and contract manufacturers.
Review supplier quality data and support incoming inspections and non-conformance investigations.
Collaborate with suppliers on corrective actions, technical reviews, and quality improvements.
5. Change & Configuration Management
Lead and document Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs).
Ensure product changes are evaluated, approved, and implemented effectively through cross-functional coordination, verification and validation.
Maintain accurate Bill of Materials (BOMs), drawings, and revision control.
6. Team & Cross-Functional Collaboration
Lead and support technical staff, providing mentoring and development.
Collaborate with Regulatory, Production, Sales, and R&D teams to ensure quality and technical alignment across the business.
Manage and Lead Engineering team, meeting KPI's and continually improving on processes.
7. Product / Market Development
Lead market evaluation and product concepting, working with key stakeholders and designers to delivery conceptual ideas to the external product development teams.
Ensure documentation is correctly recorded, monitored and maintained.
8. Training
~ Lead and support technical / engineering staff, providing training and evaluation to measure and state competence.
Qualifications & Experience:
~ Bachelor’s degree in Engineering (Electrical, Mechanical, or Biomedical preferred) or related technical discipline.
~5+ years in a technical or engineering, quality management role in medical or aesthetic device manufacturing.
~ In-depth knowledge of ISO 13485, MDR, and QMS principles. (ISO9001 also applicable).
~ Demonstrated experience in fault finding and root cause analysis.
~ Strong technical writing skills with experience creating and managing technical documentation.
~ Experience managing suppliers and leading change control processes.