San Francisco Bay Area, CA
Senior Quality Engineer
Santa Clara, CA
About the job
Use multidisciplinary engineering knowledge to design, develop, verify and monitor innovative medical devices or components/subsystems in support of company’s strategic plan. Support and lead Quality objectives by planning, managing, implementing and ensuring continued compliance with the quality system.
Major duties and responsibilities:
- Support quality operations to ensure continued compliance with applicable regulations/standards and provide the necessary training to ensure awareness of personnel.
- Contribute to quality initiatives and functions to ensure effectiveness of the quality management system, including but not limited to, product and process monitoring, data analysis and applying statistical techniques, audit support, purchasing and verification, control of equipment, etc.
- Perform quality functions such as procedure writing, inspection, testing and reviewing documents for accuracy and application of procedures or standards.
- Assess opportunities for improvement and need for changes to the quality system by systematically monitoring and reviewing data pertaining to the organization, product or process changes, non-conforming product, changes to regulations/standards, complaints and feedback.
- Own and support activities pertaining to complaint handling, vigilance and medical device incident reporting by understanding and implementing the requirements based on the regions SMM markets its devices and documenting/addressing complaints in a timely manner to ensure compliance with the applicable regulations.
- Work cross functionally to help identify root cause and any necessary corrective actions.
- Qualify suppliers and monitor supplier performance to ensure product meets specified requirements.
- Lead investigations, root cause analysis, and determination of required action to be taken in response to non-conforming product or quality system processes using a risk based approach.
- Assist in the development of dFMEAs (Design Failure Mode Effect Analysis) and pFMEAs (Process Failure Mode Effect Analysis) and control plans where required.
- Facilitate validations and component acceptance activities.
- Maintain traceability, identification, documentation and applicable records to provide evidence of product and processes meeting requirements.
- Apply broad engineering knowledge to the design and development of new products as well as product changes and enhancements which are consistent with a zero defect level as well as low product cost.
- Solve multidisciplinary engineering problems at the component through system level.
- Conduct testing utilizing existing test protocols or develop new ones as needed.
- Complete projects (including product enhancements) in a manner consistent with corporate objectives.
- Contribute to the intellectual property position of the company via invention and patent applications.
- Maintain accurate documentation of concepts, designs, drawings, and processes.
- Ability to coordinate and manage project design history file and associated activities.
- Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products.
- Provide multidisciplinary engineering and technical support of products introduced into both the domestic and international markets as well as physician in-service programs.
- Maintain GMP systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post production GMP compliance in coordination with the Document Control, Clinical, and Quality Assurance functions.
- Provide multidisciplinary engineering support in the resolution of product complaints and/or safety issues.
- Provide guidance to associate engineers and technicians on engineering/test activities.
- Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and applicable regulatory requirements.
Education and other requirements:
- BS Engineering and minimum 4 years engineering experience supporting a medical device or related environment
- Knowledge of national and international regulations applicable to medical devices including; 21 CFR 820 (Quality System Regulations), ISO 13485, and MDD 93/42/EE.
- Working knowledge of engineering terminology and concepts and related software applications (Word, Excel, Project, Solidworks/CAD, Statistical software)