The Quality Engineer will be a crucial contributor to ensuring that our medical devices consistently meet the highest quality standards and comply with all relevant regulatory requirements. This key position will involve developing and implementing robust quality strategies, fostering a culture of excellence, and collaborating closely with cross-functional teams to drive and sustain continuous improvement initiatives. Additionally, the Quality Engineer will be responsible for conducting thorough assessments, identifying potential risks, and ensuring the effective implementation of corrective and preventive actions. By leveraging industry best practices and staying current with evolving regulatory guidelines, this individual will help maintain our commitment to producing safe, reliable, and high-quality medical devices. Strong problem-solving skills, attention to detail, and a proactive approach to quality management will be essential for success in this role.
Principal Duties and Responsibilities include the following:
- Provide expert quality engineering support to Operations, including General Manufacturing, Inspections, and Sustaining other engineering projects.
- Oversee quality processes within Supplier Management, supplier assessments, audits, corrective actions, and managing performance scorecards.
- Collaborate closely with suppliers to resolve any quality-related issues and drive continuous improvement initiatives.
- Develop, review, and approve documentation for manufacturing process equipment validation, including IQ/OQ/PQ protocols.
- Monitor and track nonconforming materials and CAPAs, leading Material Review Board (MRB) efforts as required.
- Manage equipment control processes, including qualification, validation, tracking, and initiating calibration and preventive maintenance activities as needed.
- Conduct process validations, including protocol writing, report generation, and contributing to the development of test methodologies and fixturing.
- Execute incoming inspections and lot release procedures, ensuring the review and approval of all quality records.
- Contribute to the creation and updating of risk management documentation, including FMEAs, risk analysis files, and risk assessments.
- Drive continuous improvement of Quality Management System (QMS) processes and systems.
- Assist in the investigation of device complaints related to returned products.
- Monitor, evaluate, and report on key quality system metrics to ensure ongoing compliance and performance.
- Develop, maintain, and update inspection and quality control procedures to ensure consistency and effectiveness.
- Provide support for incoming inspections, including review of lot history documentation to ensure accuracy and compliance.
- Actively participate in project teams, offering technical expertise and guidance to ensure adherence to quality standards.
- Ensure compliance with established Quality System procedures and company policies.
- Perform other related duties as assigned by the supervisor, aligning with quality objectives and regulatory standards.
Qualification Requirements:
Education:
- Minimum B.S. in engineering, life science or related discipline.
Experience:
- At least five (5) years' work experience in the regulated medical device industry is preferred.
- At least three (3) years' work experience in quality engineering or quality assurance.
Knowledge/Skill:
- Excellent verbal and written communication skills, including ability to effectively communicate with internal and external stakeholders
- Excellent computer proficiency in MS Office Word, Excel and Outlook
- Working knowledge and application of FDA QSRs and ISO 13485 requirements. Audit experience a plus.
- Demonstrated knowledge of statistical methods and principles
- Ability to create and maintain project plans.
- Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary customer service
- Ability to collaborate in a team environment as well as work independently
- Ability to be proactive and collaborative in a dynamic start-up environment and wear multiple hats as necessary
Working Location and Conditions:
- Hybrid position at corporate office in Los Gatos, CA
- Ability to communicate and participate in meetings and respond to phone calls and emails.
- Ability to move within the office environment, such as attending meetings or retrieving files from storage areas.
- Ability to lift and carry office supplies, files, or light equipment (typically up to 25 pounds) as needed.
- Ability to occasionally reach for supplies, documents, or equipment stored on shelves or in cabinets.
- Must be willing to travel 25% of the time