In 2011, Sight Sciences was founded to change the way the practice of ophthalmology and optometry thinks about and treats the leading causes of eye disease.
Supported by leading medical technology and private equity investors, Sight Sciences operates two business lines: surgical and non-surgical systems. Its surgical product portfolio consists of the TRAB™360 and VISCO™360 surgical systems for use by ophthalmologists. Its non-surgical product portfolio consists of its TearCare™ technologies for use by ophthalmologists and optometrists.
The Senior Quality Engineer is responsible for establishing the technical quality policies, procedures and objectives related to Operations and Product Development and. This individual reports directly to the VP of Quality Assurance and interacts with a broad range of engineering and management team members to set and implement compliant engineering policies and strategies. Oversees all aspects of an organization's quality engineering functions ensuring products meet all applicable standards and government regulations. Provides support to the Change Management program, Document Control activities, and training for Quality Systems, including, but not limited to oversight of contract manufacturer activities, verification of changes, filing of approved documents, and other duties as assigned. He or she will evaluate and implement protocols and methods to inspect and test in-process raw materials and finished products, and ensure that they are in compliance with internal and external safety, quality and regulatory standards requirements for distribution. The person in this role will perform analysis and identify trends for quality performance, and recommend corrective actions when necessary.
MAJOR DUTIES AND RESPONSIBILITIES
• Support company goals and objectives, policies and procedures that comply with FDA Quality System Regulations (QSR), ISO 13485, and any other applicable domestic or international requirements.
• Assures compliance of the technical aspects of the company by successfully integrating these activities with other functional areas within the company, including: Quality, Regulatory / Clinical, Operations, R&D, and Finance.
• Creates long-range quality plans for the organization focusing on: Design Control, Risk Management, Statistical Sampling Methods, Supplier Quality, NCMRs, Manufacturing Quality Control.
• Coordinates the reporting, analysis, and resolution of material non-conformances via various quality engineering techniques and Material Review Board actions.
• Conducts quality audits and coordinate development and implementation of preventive actions.
• Provides engineering and technical support of products introduced into both the domestic and international markets.
• Oversees Quality-specific activities related to qualification of new products such as biocompatibility, shelf life, packaging integrity testing, sterilization and test method validation, product performance monitoring plans etc.
• Develops Quality Assurance specifications, test methods, sampling plans, and related written procedures
• Conduct testing utilizing DOE methodology and other experimental design tools along with generating complex written reports.
• Maintain GMP systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post-production GMP compliance. Provide support in the resolution of product complaints and/or safety issues.
• Distribute copies of controlled documents to other company locations or systems as needed.
• Perform word processing duties related to writing policies, procedures, assembly instructions, and other controlled documents.
• Communicate Document Control requirements and guidelines to cross-functional teams.
• Participate in the development of slides/data for Management Review.
• Participate in Notified Body audits, regulatory inspections or 3rd party audits.
• Maintain a professional, credible image with regulatory agencies, key physicians, consultants, vendors, and co-workers
Education Requirements: BSME or MSME or equivalent
Experience Requirements: Minimum of 5-10 years of demonstrated leadership in the medical device industry or a directly related field. Experience leading Quality-related processes in commercial organizations.
• The ability to apply principles of logical and scientific thinking to define problems, collect data, establish facts and draw valid conclusions.
• Thorough working knowledge of the medical device industry is required.
• The ability to interpret an extensive variety of abstract and concrete concepts and synthesize them into technical, financial, regulatory, and business solutions.
• Strong statistical skills
• Strong written and verbal communication skills to communicate effectively at all levels.
• Good presentation skills to deliver speeches and/or presentations effectively to a variety of audiences.