Job Description

Title: Quality Engineer II
Location: San Diego, CA – On-site

GENERAL POSITION SUMMARY
Mid-level individual responsible for various Quality Assurance functions and activities of medical devices in compliance with FDA, ISO 13485, and other recognized industry standards regulations. This position requires the willingness and ability to mentor Quality Assurance Inspectors and Technicians.

SPECIFIC DUTIES AND RESPONSIBILITIES
• Supports the design of medical devices and components from design transfer into manufacturing by representing Quality Assurance.
• Defines and implements inspection (visual, dimensional, functional testing) and initiates process by preparing inspection plans, identifying and obtaining required fixtures and test/inspection instrumentation.
• Coordinates NCMR and MRB activities for assigned products, timely resolution of nonconformities, issuing and/or monitoring corrective actions associated with nonconformances and deviations.
• Supports manufacturing and suppliers through corrective and preventive actions, assistance in on-site resolution of quality and process related issues.
• Contributes to the successful completion of Process Validation initiatives by facilitating validation master plans and the qualification activities required to meet validation requirements. This includes generating and/or reviewing Process Flows, Control Plans, Design of Experiments, Measurement Systems Analyses, and Process Capability Analyses.
• Perform Gage R&R and correlation studies.
• Reports progress and status of assigned projects on a timely basis with emphasis on reporting results to Quality Assurance Management
• Collect, analyze, and interpret statistical data with adequate quality engineering tools. Performs analyses and provide reports to management as required.
• Provide support and guidance to other quality groups/members to assure efficient completion of task or project requirements.

EDUCATION & EXPERIENCE REQUIREMENTS

EDUCATION
Bachelor’s degree required in an Engineering or Science discipline.

EXPERIENCE / SKILLS
• At least three years’ experience in a Quality Control or Quality Assurance Engineering position in a Medical Device Company.
• Working knowledge of FDA, ISO13485, ISO 14971 Risk Management Standards, RoHs and WEEE Directives.
• Experience with medical device capital disposables and equipment.
• Statistical knowledge and Minitab experience. Demonstrated ability to document test data, analyze test results utilizing statistics, write clear and concise lab reports, and make recommendations to evaluate product.
• Sufficient proficiency in change control to add, modify and delete quality requirements in QMS documents.
• Manufacturing process knowledge.
• Excellent organizational and communication (oral and written) skills. Ability to work on teams as well as individually. Able to set and meet goals. Organized and detail oriented. Problem solving and analysis skills.
• Provide solutions to a wide range of challenges. Work independently and with team members to determine and develop solutions that are thorough, practicable, and consistent with organizational objectives.

PHYSICAL REQUIREMENTS
May require the ability to lift 20 pounds. Employer may make reasonable accommodations to help some physically challenged employees.