Senior Quality Assurance Engineer- Manufacturing

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 Senior Quality Assurance Engineer is responsible for supporting and improving our quality management systems, processes, and product reliability. This position involves working closely with production teams, and leading root cause analysis efforts to address manufacturing and supplier quality issues. The Senior Quality Assurance Engineer plays a pivotal role in driving continuous improvement, ensuring regulatory compliance, and enhancing product quality to exceed customer expectations.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Work closely with cross-functional teams, including production, engineering, and supply chain, to ensure quality standards are met in every phase of production.
• Collaborate with suppliers to ensure that incoming materials and components meet required quality standards. Perform supplier audits and maintain the Approved Supplier List. Develop and Improve inspection plans for parts and subassemblies and provide technical guidance to Receiving Inspectors in areas of expertise.
• Review and Approve Device History Records, Nonconformance Dispositions, Inspection Plans and Assembly History Records. Provide support to the RMA process as required.
• Participate in the Engineering Change Process by reviewing and evaluating recommended changes and determining impact of changes on current inspection activities.
• Investigate electrical quality issues and defects, leading failure analysis to identify root causes and implement effective corrective and preventive actions (CAPA).
• Provide quality oversight for manufacturing processes, review of reworked material, label verification and the release of products.

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 Electrical Engineering, Electronics Engineering, or a related discipline.
• Proficiency in reading electrical schematics, PCB layout knowledge, and familiarity with test equipment (e.g., multimeters, oscilloscopes).
• Minimum 7+ years' experience in a manufacturing environment within a regulated environment, i.e. ISO9001, ISO13485.
• Ability to work and communicate effectively with other departments such as engineering, operations, and supply chain.
• The ability to travel throughout the U.S. is required at less than 10%.
• Understanding of IPC standards (e.g., IPC-A-610 or 620).
• Strong Microsoft Office skills.

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

While performing the duties of this job, the employee is regularly required to communicate verbally and written. 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