Associate Quality Engineer
- Irvine, CA, USA
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.
Position is responsible for supporting all aspects of the Quality Assurance Program, including internal/external quality issue resolution, supplier quality issues, supplier audits, CAPA's, Customer Complaint Analysis, to drive product and process improvements.
This involves providing statistical information for quality improvements by identifying testing methods and sampling through the use of various statistical tools.
This position is granted the authority by the Director of Quality to take any actions required to fulfill the scope, duties and responsibilities of this position.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Provide root cause analysis support and drive the implementation of corrective actions
- Interface with Engineering and Operations to ensure transfer to production of new products meeting all quality system requirements
- Provide guidance to production and quality assurance on the use of statistical tools, i.e. SPC, Sampling Methods, and Gage R&R Studies
- Conduct Supplier Audits and follow-up on any open corrective actions
- Participate in complaint investigations, failure analysis of returned products and production issues
- Provide support for continuous improvement of the quality management systems
- Work with Manufacturing to coordinate and monitor production processes to ensure compliance to FDA QSR, ISO 13485
- Write software validation protocols and reports for new and revised software applications
- Write process validation protocols and reports for new and improved manufacturing processes
- Develop sampling plans by applying attribute, variable and sequential sampling methods
Education and/or Experience
- Four year degree in Engineering or related field required
- Medical device experience preferred
- Working knowledge of quality system regulations, i.e., FDA QSR, ISO 13485
- ASQ Certification as a CQE or CQA desired
- Strong skills in technical writing
- Demonstrates knowledge of statistical sampling and analysis
- Ability to effectively problem-solve through critical thinking and root-cause analysis with minimal direction and make decisions with confidence
- Good 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
- Word processing skills, including Microsoft Word, Excel, and Power Point
BIOLASE offers 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)