Quality Assurance Auditor

At CooperVision, a division of CooperCompanies, we're driven by a unifying purpose to help people to experience life's beautiful moments. We are connected through our shared values - dedicated, innovative, friendly, partners, and do the right thing. As a leading global manufacturer of contact lenses, we are committed to helping improve the way people see each day. Through our diverse lens portfolio, we tackle the toughest vision challenges - including astigmatism, presbyopia, and childhood myopia. We offer the most complete collection of spherical, toric, and multifocal products available, enabling us to fit 99% of all contact wearers. Learn more at www.coopervision.com .

Job Summary:

Ensures processes and product conform to quality standards through the execution of process audits and product inspections at various points in the manufacturing process. Execute sterilization functions and assist non-conforming product investigations as required.

Knowledge, Skills and Abilities:

Ability to use basic optical metrology equipment to determine product acceptance including Vertexometer, SAG Optimec, and Rehder Gauge. Understanding of calibration and sources of measurement errors. Ability to understand inspection and test methodologies to ensure audits and inspections are carried out in valid manner, which requires the ability to read specifications, a basic understanding of product sampling, and ability to identify and segregate nonconforming material. Ability to understand Quality Assurance concepts including measures of central tendency, SPC/Control Charting, quality improvement, quality audits, and Problem-Solving Tools such as fault tree and 5-Why analysis. Ability to apply mathematical concepts such as fractions, percentages, ratios, proportions, scientific notation and general statistics to practical situations. Ability to understand Standard Operating Procedures (SOP), technical procedures, standards, and basic Quality System concepts. Strong oral and written communication skills in English. Excellent time management and prioritization skills. Highly motivated, self-directed, and attentive to detail. Ability to work in a team-oriented, collaborative environment. Strong computer skills working with Microsoft Office Suite, eQMS and ERP software.

Work Environment:

Lens manufacturing and laboratory environment with some exposure to manufacturing materials, chemicals, and solvents. Working near and around moving mechanical parts. After hour support may be required. Lifting up to 25 pounds as needed. Limited exposure to noise, dust, and hot or humid conditions.

Experience:

2 years' experience in a manufacturing environment preferred Experience in a quality role is preferred. Regulated industry experience preferred (e.g. medical device, automotive, or aerospace)

Education:

High School Diploma or GED equivalency is preferred. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace. For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $19.50 and $25.00 per hour and may include cost of living adjustments. The actual base pay includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits. Perform characteristic analysis utilizing metrology equipment for analyzing product specifications including power, cylinder, axis, diameter, and lens thickness. Audit in-process products to ensure conformity to Quality standards and report any specification conditions to the Quality Supervisor and Quality Coordinator. Assist in the collection and analysis of process and product quality audits and escalate to management and production staff for problem solving as appropriate. Perform incoming raw material inspection audits as needed. Review Device History Record (DHR), product label and package review, and general process audits. Review Sterility records and final releases product and perform associated tasks with Sterilizer operation including load staging and unloading, batch/system recording, and sterilizer operation as needed. Initiate and assist in Non-Conformance Reports (NCRs) investigations. Report any deviations from established procedures or product standards to the QA Supervisor and QA Coordinator. Responsible for the final release of product. Support or assume QA Coordinator responsibilities as needed, including coverage during absences. As business needs dictate, work extended hours to complete daily department goals or tasks, including mandatory overtime. All other duties as assigned.

Travel:

This position does not require travel.