Careers

Job Brief

Candela is recognized globally for its innovating energy-based technologies that change lives and our new brand embodies our continued commitment to innovating medical aesthetic treatment solutions based on solid science and effective outcomes.

We aspire to provide the highest levels of clinical, technical and customer support, and continue to build on the longstanding partnerships of trust we’ve established with physicians, their practices and the patients they treat.

Every role is important at Candela:

Candela seeks an experienced Sr. Director of Global QA Compliance who will be responsible for Candela’s Global QA and compliance functions with a focus on day-to-day operations across the entire portfolio. The Global Operations organization is responsible for driving transformational improvement to create operational excellence, robust processes and an environment of disciplined execution.

The successful candidate will have the relevant expertise, experience and motivation to drive disciplined process approaches that change and improve Candela’s way of working and delivering sustainable results in Operations. 

• The ideal candidate exemplifies high technical skills, global leadership, team development acumen, effective engagement, change management skill and the ability to work and mentor junior employees and communicate and work with senior management.
• She/he will manage across organizational matrix, focused on on-time-delivery of high-quality systems with cost efficiency.  Frequent inter-organizational interaction across multiple functions, especially within operations, regulatory, supply chain, and sustaining engineering, as well as other functions within global quality. 
• Ensures that all members of Quality team understand and are aligned with the Candela QMS and execute accordingly.  Maintains effective contact and working relationships with relevant Candela locations and vendors worldwide.
• This role is a key contributor to the global quality and operational strategy and execution of that strategy.

Essential Skills to be a top contributor in this role:

• Support and drive organizational achievement of MDSAP and MDR certification with primary focus on the operational quality and QMS.

• Establish, implement, and maintain the GxP Quality Management System for internal needs and ensure GxP compliance to these systems
• When needed, partner with sustaining engineering and supply chain management in addressing supplier quality issues
• Lead Quality Management Reviews (QMR) and setup site dashboards and KPIs to measure site compliance globally.  Lead global QMR.
• Develop and maintain compliant quality system that adheres to FDA regulatory expectations.
• Lead / facilitate effective corrective and preventative action (CAPA) management.

• Leads the audit readiness program and will host or support regulatory audits. Some travel required to support this activity.
• Support risk-based approaches in driving solutions to organizational challenges
• Champion and oversee continuous improvement for QA initiatives and the CAPA program
• Develops Quality strategy and the development, maintenance and adherence to quality management systems and continuous process improvements.
• Drives standardization and implements best practices.
• Ensures development of effective staff, systems, and procedures within areas of responsibility.

•  Serving as Management Representative for notified bodies
• Manage to clear objectives and support continuous improvement of quality across the organization

• Work with global head of quality and senior operations and other senior leadership on understanding and prioritizing any remediation activities
• Support the organization on the compliant integration of acquisitions into the global QMS
• Act as an effective team member in the execution of Quality functions in compliance with FDA QSRs (Design Control, CAPA, etc.), ISO 13485 and other national and international quality and regulatory requirements and standards
• Understand and help implement global processes of the QMS
• Analyze complaint data, post market surveillance and risk analysis to assist in the identification of potential product improvements.

• Successful implementation of compliance KPIs and dashboards for local and global functions
• A global audit readiness program that identifies, manages and reduces risk
• Achievement and Maintenance of MDSAP and EU MDR QMS certifications
• Integration and deployment of global QMS requirements, where needed or as part of M&A activities
• Define and drive the GxP Quality vision and mindset of Candela Medical in close collaboration with the executive leadership team.
• Define clear Quality objectives and ensure progress and cross-functional completion of responsibilities.
• Use judgment to develop pragmatic solutions, and drive risk analysis and mitigation strategies.
• Oversee all aspects of audit readiness and support achievement of MDSAP and MDR certification globally.
• Provide leadership, guidance, and direction to staff consistent with CFR 820 and ISO 13485:2016 (5) Drive a clear vision of quality using dashboards, QMR and KPIs cross functionally.
• The Sr. Director/ Director of Global QA Compliance will have three (3) direct reports with two (2) located in Wayland and one (1) in Yokne’am, Israel.  The Sr. Director/ Director of Global QA Compliance will report to the VP Global Quality at Candela who resides in Wayland, MA.

Background required for this role:

• Bachelor’s degree in Engineering or related field, plus 5-10 years of related experience in the medical device or another regulated industry with at least 5 years in a senior quality role
• Expert understanding of appropriate global medical device regulations, requirements and standards, including Quality Management System (ISO 13485) and Medical Device Regulations (21 CFR 820) is a must, including EU MDR and MDSAP
• Project Management (development of project plans, status meetings, project reporting, etc.) and organizational change movement
• Ability to analyze information and come to conclusions based on presented data
• Ability to manage multiple projects in a dynamic and fast paced environment
• Ability to communicate effectively both orally and in writing including to cross-functional partners and senior management
• Strong manager with track record of recruiting and developing teams and individual talent
• Self-motivated and ability to manage time working on multiple projects simultaneously
• Demonstrated competency in computer skills: MS office applications, query tools, and enterprise database systems, Service Max and Agile is a plus

This job description is not all inclusive and is intended to capture a majority of the job functions.  Special projects and other tasks may be required by management.