The QA Specialist (TEMP) will participate in receiving, reviewing, and processing product and customer complaint handling and risk management, as well as interdependent and additional departmental support. With limited supervision, assist the Quality Group in the required areas as listed in General Responsibilities.
- Interface with customers regarding the details and documentation of complaint records, investigation, and risk management
- Responsible for collecting data related to product complaints and entering collected information into the complaint management system
- Immediately notify the management of Complaint Management functions of issues that suggest a potential regulatory or business risk
- Request and document any additional information needed to thoroughly evaluate and investigate the complaint, including coordinating the procurement of complaint samples
- Send written or electronic acknowledgement of the complaint to the customer
- Determine the regulatory reportability of each complaint in accordance with business procedures and regulatory guidelines
- Document all contact with complainants in the system
- Manage workload to ensure completion within timeframe
- Ability to establish rapport with internal/external customers, peers, and employees in all departments
- Support activities and documentation related to corrections, corrective actions and preventive actions to correct and eliminate the potential for non-conformances
- Works constructively with cross-functional departments for timely resolution of quality issues
- Tracks the timeliness of closed reports and provides feedback to the organization through quality metrics
- Adhere to and ensure the compliance of all company policies, guidelines, procedures and housekeeping standards
- Minimum 3-5 years working in a regulated environment, preferably in the medical devices
- Experience with Quality Management System (ISO 13485) and Medical Device Regulations (21 CFR 820)
- Prior experience processing medical device complaints or quality assurance/regulatory affairs background is preferred
- Customer service/complaint handling and problem-solving skill
- Basic computer skills (i.e. Microsoft Office - word processing, spreadsheets, databases); SalesForce, ServiceMax and Oracle experience preferred
- Documentation, negotiation, time management, and communication skills (both written and verbal)
- Reasoning ability, support and prioritize projects, adapt to shifting priorities, work with minimal supervision, able to resolve problems/conflicts
- Must be extremely detail-oriented
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.
Syneron Candela is a leading global aesthetic device company with a comprehensive product portfolio and a global distribution footprint. The Company's technology enables physicians to provide advanced solutions for a broad range of medical-aesthetic applications including body contouring, hair removal, wrinkle reduction, tattoo removal, improving the skin's appearance through the treatment of superficial benign vascular and pigmented lesions, and the treatment of acne, leg veins and cellulite. The Company sells its products under three distinct brands, Syneron, Candela and CoolTouch, and has a wide portfolio of trusted, leading products including UltraShape, VelaShape, GentleMax Pro, VBeam Perfecta, PicoWay, Profound and elos Plus. The company markets, services and supports its products in 86 countries. It has offices in North America, France, Germany, Italy, Portugal, Spain, UK, Australia, China, Japan, and Hong Kong and distributors worldwide.
Most recently, Syneron-Candela was acquired by Apax Partners, a leading global private equity advisory firm. This acquisition is a strong recognition of Syneron Candela leadership in the aesthetic medical device market, its leading world-class technology and unique global footprint. These exceptional assets are a result of the many years of hard work of our skillful and dedicated employees all over the world. We are confident that Apax will add significant value and expertise as Syneron Candela executes on its growth strategy while delivering innovative technologies to our customers and patients. We are looking forward to this partnership to continue its strong growth trajectory, and to seeing the even greater benefits it can deliver for customers and patients.
Location/Region: Wayland, MA (US)