Quality Engineer II, Design

The Quality Engineer II, Design, based in San Clemente, CA directly supports the full product lifecycle of innovative ocular medical device development; responsibilities include the execution of design control deliverables, risk management activities, Design History File compliance and leading assessment/implementation of design changes to already approved medical devices. This role will support the development of new product designs as well as the maintenance and enhancements of existing products.

Responsibilities & Work Experience:

Design Control:

Working with development teams to assure:

• Clear and concise user requirements, product specifications, plans, verification and validation studies, risk management strategies and other relevant design control deliverables,

• Test protocols that include qualified and repeatable test methods, appropriate risk-based sample sizes and clear test instructions that produce meaningful data,

• Robust reports which include appropriately analyzed test data to support regulatory submissions and product launches,

• Transfer plans that include complete DMR documents, quality control plans, training plans, approved suppliers and process validations,

• Complete and accurate design history files.

Risk Management:

• Maintain the risk management plans for all product lines ensuring compliance with ISO 14971.

• Leads Risk Management activities for effective product development and operational activities.

• Ensure feedback loops are implemented and effective.

• Integrate risk management throughout the quality management system.

• Provide risk analysis leadership for all departments.

Quality System:

• Ensure all design control and risk management documents are maintained and meet regulatory requirements.

• Participate in and lead investigations for CAPA, manufacturing or quality system projects.

• Assess and improve quality system processes through data monitoring and trend analysis.

• May participate in internal and supplier audits, conducting audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions.

• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

• Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.

• Mentor for technical guidance for identifying and resolving quality issues.

Other Duties as Assigned:

• Additional other duties and projects as required to facilitate R&D, Operations, Production, Engineering, Clinical and Regulatory goals and objectives.

• 4 to 7 years work experience in a production or engineering environment and 3+ years as an engineering technician work.

• 3+ years of medical device experience required.

• Working understanding of 21 CFR Part 820 and ISO 13845 and 14971 requirements

• Excellent documentation skills with attention to detail and accuracy

• Must be self-motivated, goal-driven and results-oriented team player

• Must be organized and able to coordinate activities with internal departments

Education:

Bachelor’s Degree in Science or Engineering