Quality Systems Analyst
- 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 Quality Systems Analyst is a technical position that is responsible for reviewing, documenting and performing evaluation and generating reports of quality data sources including but not limited to customer complaints, internal non-conformances, and supplier monitoring data.
The Quality Systems Analyst will be involved with review of complaint information and evaluations, internal NCMR (non-conforming material reports), and review of supplier performance data. In addition, they will establish and maintain databases for all these associated data inputs.
Additional responsibilities include preparation of all associated information and graphical content for the company’s Management Review process, in addition to the maintenance and report of the Training Matrix and compliance to employee training requirements.
The position will also be part of the Internal Audit program, where the employee will participate in internal audits as an assisting Auditor, and help prepare the audit report and appropriate follow-up activities.
This person is responsible of all activities associated with various BIOLASE data sources and products and process information according to FDA, European and Canadian medical device requirements.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
The Quality Systems Analyst will be responsible for all tasks related to the review, compilation, database creation and input, and analysis of various quality data sources. In addition, will be responsible for the development of metrics and trending for reports to management review and other scheduled data review meetings.
- Basic understanding of Good Manufacturing Practices (GMPs), FDA Code of Federal Regulations (CFRs), ISO13485, Medical Device Directive, and Canadian Medical Device regulations.
- Responsible for compliance with applicable BIOLASE policies and procedures.
- Provide management with product quality data and trending reports.
- Responsibilities include developing proper systems for handling and storage of key data and analysis.
- Timely and accurate reporting of data by type and frequency requirements of management.
- High degree of technical competence and communicative ability in order to receive, evaluate, investigate data and respond to internal customers and other stakeholders.
- Must be able to work under pressure and deal effectively with the needs of the business.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Bachelor's degree in computer science, economics, statistics, mathematics, engineering discipline or similar field, or an equivalent combination of education plus work experience.
Two plus years of experience in data analysis, preferably in a regulated medical products manufacturer. Knowledge of and experience using MS Excel, MS Access or equivalent statistical tools to analyze
Excellent skills in the presentation of data into tables and graphs for review by management. Strong PC/Data Entry Skills
ESSENTIAL TECHNICAL SKILLS include the following:
- Through understanding of computer database structures and other data collection and analysis methods
- Highly skilled in database creation, as with MS Access or similar SQL applications for extraction and compilation of data from various sources into a master database
- Highly skilled with Excel to further compile and review data and generate graphs and reports for management (including Pivot Tables, V-Look up, and Data Analysis Toolpack)
- Statistical Analysis skills including the ability to use programs such as R, or other statistical programs
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)