Quality Engineer II

San Clemente, CA

About the role

The Quality Engineer II will support the development and manufacturing of Class III medical devices. This individual will work with Medical Safety, Product Development, and Manufacturing to resolve product quality issues, support manufacturing process changes, product design improvements, and the implementation of new products.

Responsibilities

• Work in Quality Engineering and with other functional groups to support product nonconformity investigation.
• Review process changes and resolve product quality issues.
• Initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate.
• Lead and perform complaint evaluation as appropriate.
• Train, coach, and guide lower-level employees on routine procedures.
• Develop trend requirements to support the QA/QC department in NCR, CAPA, and SPC processes for incoming inspection, process, and vendor operations. Evaluate data and identify trends to develop innovative solutions.
• Develop and establish effective quality control.
• Write, review, and/or approve process and product validation protocols and reports, equipment qualifications, and document change orders.
• Use statistical tools to analyze data, make acceptance decisions, and improve processes.
• Provide technical assistance/oversight in defining and conducting both internal and external product and process validations and requirements, working closely with Product Development, Applied Research, and Manufacturing personnel as well as vendors. Write, perform, and/or review technical documents such as Validation Protocols, Test Procedures, and Test Reports.
• Conduct, document, and maintain risk analyses for all development products and comply with risk analysis, design control, and any other related procedures.
• Manage equipment and facility (including clean room) requirements, design, maintenance, calibration, and validation programs.
• Ensure compliance with all Federal, State, local, and company regulations, policies, and procedures.
• Perform other quality-related duties as assigned by management.
• Assist with creation of new efforts for quality improvement opportunities related to legacy products, continuous improvement, and customer satisfaction.

Requirements

• Bachelor's degree in Engineering or Science.
• 2-5 years of relevant work experience.
• Strong knowledge of medical device manufacturing.
• Expertise in medical product quality assurance, including requirements for test protocols and statistical techniques.
• Working understanding of GMP and ISO 13485 requirements.
• Hands-on involvement with all phases of projects.
• Experience working in a clean room and/or performing in-process assembly and manufacturing verification inspections (desirable).
• Excellent documentation skills with attention to detail and accuracy.
• Team player with strong written and oral communication skills.