Quality Assurance Engineer

Company Overview

LENSAR, Inc. is the leader in advanced robotic laser technology for refractive cataract surgery. LENSAR''s laser systems offer cataract surgeons superior precision and accuracy, while optimizing overall visual outcomes. Our mission is to take the time to understand the needs of surgeons and their patients so that we can innovate our technology to ensure we meet their dynamic needs.

Interested in starting a career at LENSAR?

As a global leader in next generation robotic laser for cataract surgery, our success depends on talented and motivated individuals who share our passion for making a difference in patients' lives. We pride ourselves on having a highly collaborative, innovative environment where initiatives and teamwork are valued, and individual efforts are recognized. Together we are one team one vision.

POSITION SUMMARY

The Quality Assurance Engineer works with Manufacturing, R&D, Purchasing and Supplier Quality Engineers to execute all Manufacturing QA activities for LENSAR. This person shall review Device History Records for accuracy and completion, monitor and trend manufacturing nonconformance data, and recommend corrective actions. The Quality Assurance Engineer will work with the Supplier Quality Engineer and Receiving Inspection to correct Supplier caused nonconformities.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Provide Quality Engineering support to manufacturing including validation activities, data analysis, report and protocol writing, problem solving and continual improvement.
• Perform device History Record Reviews for assigned product lines.
• Review nonconforming parts and sub-assemblies for proper initial disposition and root cause follow-up.
• Work with Receiving Inspection and Supplier Quality Engineering to develop inspection standards for parts and subassemblies.
• Assist production in prevention of defect occurrence and recommend process changes.
• Participate in the Engineering Change Process by reviewing and evaluating recommended changes and determining impact of changes on current inspection activities.
• Perform mechanical and other inspections in support or receiving inspection as required.

KNOWLEDGE / EXPERIENCE / SKILLS / EDUCATION

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Required:

• Bachelor's degree in technical discipline, preferably mechanical.
• Minimum 1+ years' experience in a manufacturing environment within a regulated environment.
• Strong communication and interpersonal skills.
• Strong problem identification and problem-solving abilities.
• Strong MS Office skills.
• Ability to read and interpret documents such as Engineering Drawings/ Specifications, Operating Procedures and Work Instructions.
• The ability to travel throughout the U.S. is required at less than 5%.

Preferred:

• Experience working in a regulated industry, ie. ISO9001, ISO13485.
• Experience with Solid Works.

PHYSICAL DEMANDS

These physical demands are representative of the physical requirements necessary for an employee to successfully perform the essential functions of the Quality Assurance Engineer's job. Reasonable accommodation can be made to enable people with disabilities to perform the described essential functions of the Quality Assurance Engineer's duties and responsibilities.

While performing the duties of this job, the employee is regularly required to communicate. The employee is frequently required to remain stationary and work at a computer. The employee is occasionally required to move about the facility. Some travel required.

WORK ENVIRONMENT

While performing the duties of this position, the employee frequently works in an office environment but occasionally works near moving mechanical parts, and is exposed to fumes or airborne particles, toxic or caustic chemicals, and vibration. The noise level in the work environment is usually moderate.

In addition to a competitive salary, below are further benefits/rewards offered by LENSAR, Inc.:

• Annual bonus opportunity
• Company matched 401(k) plan with eligibility day one and immediate vesting
• Employee Stock Purchase Plan (ESPP) and other company equity programs
• Employer-sponsored comprehensive health plans- medical/dental/vision
• Employer-paid disability insurance
• Voluntary life insurance
• Generous company holiday schedule
• Paid time off program
• Company-wide paid shutdown during the holidays