Quality Assurance Manager

• We're looking for a QA Manager to join US , a global leader in professional aesthetic devices for home use. Based in Caesarea, Israel.

Responsibilities: • Implement and support the Quality Assurance System to ensure compliance with ISO13485, 21 CFR 820, EU MDD, MDSAP, LVD, EMC, RED, etc.

• Define and write documents, including procedures, work instructions, and quality records, to meet regulatory requirements and product standards.

• Collaborate with cross-functional teams to understand and document processes for product development, manufacturing, and post-market activities.

• Drive tasks end-to-end, ensuring all quality-related activities are completed in a timely manner.

• Stay updated on regulatory changes and proactively implement them within the Quality Management System (QMS).

• Support and manage Notified Body audits and FDA inspections, ensuring readiness and successful outcomes.

• Work closely with stakeholders to address non-conformities, implement corrective actions, and drive continuous improvement initiatives.

• Provide guidance and support to other team members on QA/RA matters, fostering a culture of quality excellence.

• Leading or participating in continuous improvement projects to implement change within Operations.

• Participating in teams introducing new products/ processes to the facility. Defining the controls and quality standards for new products.

• Appointed as the Management Representative with the appropriate responsibility and authority.

• Appointed as Silk’n beauty Person Responsible for Regulatory Compliance (PRRC) as per Regulation (EU) 2017/745 of the European parliament and of the council of 5-April-2017 Article 15.

Qualifications:

• Practical engineering degree or higher, with a Bachelor's degree in a relevant field preferred.

• Minimum of 5 years' experience in the medical device industry, with a focus on implementing and supporting quality assurance systems.

• Strong understanding of ISO13485, 21 CFR 820, EU MDD, and MDSAP.

• Proficient in defining and writing documents, such as procedures, work instructions, and quality records.

• Experience with Notified Body audits and FDA inspections is highly desirable.

• Knowledge of LVD, EMC, RED, RoHS, and Reach is preferred.

• Excellent communication and documentation skills, with keen attention to detail.

• Results-driven, able to work effectively under pressure and meet deadlines.

• Demonstrated ability to present technical information and collaborate in a team environment. • Self-motivated, proactive, and quick self learner, with the ability to adapt to changing requirements.

• Fluency in English and Hebrew at a very high level is a must. Knowledge of other languages is preferred.