Job DescriptionCooperVision, a division of CooperCompanies (NASDAQ:COO), is one of the world's leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable, two-week and monthly contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism, presbyopia and childhood myopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visit www.coopervision.com.Job Summary:The Quality Assurance Auditor ensures that processes and product conform to quality standards through the execution of process audits and product inspections at various points in the manufacturing process. They will also execute necessary sterilization functions and will assist non-conforming product investigations as required.Responsibilities
- Audits in-process product to ensure product conforms to Quality standards and reports out of specification conditions to QA Coordinator and/or QA Supervisor. Assists in collection and analyses process/product quality audits and brings them to the attention of both management and directly with production staff for problem solving.
- Reviews Device History Record (DHR), product label/package review and general process audits.
- Reviews Sterility records and final releases product. As needed, performs additional tasks associated with Sterilizer operation including load staging and unloading, batch/system recording, and sterilizer operation.
- Assists investigations of Non-Conformance Reports (NCRs) and Corrective Action Preventive Actions (CAPA). Reports deviations from established procedures or product standards to the QA Coordinator or QA Supervisor.
- Collaborates with internal audits(or) to verify conformance with established quality systems this includes advising, working with managers and supervisors as to the possible improvements to conform to standards.
- Evaluates newly trained operations employees to provide feedback to department supervisors on training progress.
- As business needs dictate, works extended hours to complete daily department goals or tasks, including mandatory overtime.
- Carries out duties associated with the QA Coordinator as requested or in their absence.
- Responsible for the final release of product.
Travel Requirements: No travel requiredQualificationsKnowledge, Skills and Abilities:
- Ability to use basic optical metrology equipment to determine product acceptance. Examples include vertexometers, sag optimec, and rehder gauge. This also includes an understanding of calibration and sources of measurement error.
- Ability to understand inspection and test methodologies to ensure audits and inspections are carried in valid manner. This includes ability to read specifications, basic understanding of product sampling, and identify and segregate nonconforming material.
- Ability to understand Quality Assurance concepts including measures of central tendency, SPC/Control Charting, Quality Improvement, Quality Audits, Problem-Solving Tools
- Ability to understand 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 English language skills both written and oral
- 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 / around moving mechanical parts.
- After hours support may be required.
- As business needs dictates, works extended hours to complete daily department goals or tasks.
- Approximate % of time spent in the following physical activities:
- Standing - 25%
- Sitting, Walking, Bending, Stooping - 50-75%
- Hand / Eye Coordination - >75%
- Finger / wrist dexterity - 25-50%
- Grasping / Pinching - 25-50%
- Twisting -