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 a Director of Quality assures quality products and processes by establishing and enforcing quality standards, testing material and products.

• Establishing a quality assurance system and team that promotes customer satisfaction and positively impacts financial performance of the company’s product lines
• Serves as Management Representative
• Oversees the training of employees as to their impact in the quality management system
• Develops, implements, manages and integrates a QMS
• Serves as the primary quality control resource for problem identification, resolution, loss reporting, and continuous improvement
• Maintains quality assurance staff by recruiting, selecting, and overseeing orientation and training of employees
• Maintains quality assurance staff job results by overseeing coaching, counseling, and disciplining employees; planning, monitoring, and appraising job results
• Supports concurrent engineering efforts by participating in design development projects representing quality assurance
• Establish and implements metrics (process capability, control charts, measurement quality) for monitoring system effectiveness and to enable managers to make sound product quality decisions
• Directs and provides feedback on root-cause analysis and other problem-solving activities to identify effective corrective actions and process improvements
• Monitors vendor performance and establish criteria and rating system for critical vendors
• Oversees calibration
• Ensures reporting on supplier quality and works with suppliers to achieve and maintain high quality standards
• Reports to management on quality issues, trends and losses
• Participates in internal and external quality audits
• Interfaces with supplier and customer quality representative concerning problems with quality control and assure that effective corrective action is implemented
• Oversees on going customer service complaint processes
• Must be able to work cooperatively with the several departments that have a vital interest in product approval including manufacturing, clinical, regulatory and R&D and must have outstanding management skills to operate growing QC department.
• Maintain and continuously improve as needed the corporate Quality Management Program, including Risk Management and Quality Management Review meetings

Essential Skills to be a top contributor in this role:

• Bachelor’s degree, or equivalent number of years of experience
• Minimum 10-years’ experience in QA systems implementation
• Minimum 5-years’ working in a regulated environment, preferably in the medical devices or pharmaceutical industries
• Experience with Quality Management System (ISO 13485), MDSAP (Medical Device Single Audit Program), Medical Device Regulations (21 CFR 820) and applicable regulatory requirements and standards
• Self-motivated, able to accomplish multiple assignments simultaneously
• Strong organizational and problem-solving skills
• Demonstrated competency in computer skills: MS office applications, query tools, and enterprise database systems
• Must be able to communicate appropriately and adequately to all management levels, including group presentation experience
• Demonstrated experience/results in Quality System tools and problem solving.
• Advanced computer skills
• Detail-oriented