- Irvine, CA
BIOLASE, Inc. is a medical device company that develops, manufactures, markets, and sells laser systems in dentistry and medicine and also markets, sells, and distributes dental imaging equipment,
including CAD/CAM scanners. BIOLASE’s products are focused on better enabling clinicians to repair and restore patient’s dental conditions while reducing the pain, fear, and anxiety generally associated with dentistry. BIOLASE is committed to elevating the standard of care in dentistry, while enabling clinicians to achieve better business returns.
The Complaint Specialist is a techncial position that is responsible for receiving, reviewing, and documenting complaint evaluations of all BIOLASE products according to FDA, European and Canadian requirements for medical device customer complaints. This position primarily interfaces with the service and operations departments in the identification and resolution of customer complaints.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Include the following, in addition to other duties assigned:
Establish and maintain complete complaint files and databases for all customer complaints, according to US and International regulatory and compliance requirements.
Review all received complaints to identify if a complaint is reportable under the Medical Device Reporting (MDR) guidelines in the US or other international Vigilance system requirements.
Maintenance of all complaint procedures, files and records according to established BIOLASE procedures.
Establish and maintain quality metrics for all product complaints, according to the direction of the Quality Systems Supervisor. Metrics may include complaints by product type, reason for complaint, reporting region, or specific time periods.
Coordination with complaint investigation and analysis personnel to understand root cause analysis in support of documentation to properly close the complaint.
Occasionally, the Complaint Specialist will be involved in specific CAPA’s related to selected complaints to provide additional data during CAPA investigations and analysis.
Possible involvement and interface with internal and external auditors, including FDA and Notified Bodies, related to the activities and documentation related to the complaint system and processes.
Interact with other functional groups inside and outside the Quality department.
Work closely with the Regulatory Affairs Group to ensure timely and accurate information is presented for any post-market surveillance and vigilance activities are needed.
Ability to quickly evaluate and analyze incoming data to ensure proper and immediate action regarding important regulatory requirements.
Excellent organizational skills and attention to detail.
Strong communication skills, both oral and written.
Ability to prioritize, multi-task and adapt to change.
Ability to work effectively in a team environment and build strong working relationships.
High degree of initiative and self- motivation with a strong sense of accountability.
Strong computer skills in Word Processing, Spreadsheets and Presentation Applications.
Strong working knowledge or database applications and medical device complaint handling software applications.
Bachelor’s Degree in technical science discipline, or Associate Degree in a technical field plus 3-5 years of experience in the medical device industry related to complaint handling or other quality assurance / compliance functions. At least 2 years of recent experience in a medical device complaint or CAPA team, or equivalent combination of education and experience.
BIOLASE offers a competitive benefits package and the opportunity to be part of a company that continues to grow based upon its existing reputation for innovative, disruptive, and practice-enhancing products. If you would like to be considered for this opening, please apply online.
BIOLASE is an Equal Opportunity Employer (EOE M / W/ Vets / Disabled)