Quality Assurance Technician

CooperVision, 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 Technician will be responsible for auditing Packaging finished goods, as well as other activities within an FDA regulated environment to ensure conformance to external regulations, as well as CooperVision’s rigorous quality standards. Immediately reports all non-conformance to established SOP’s (standard operating procedure); Utilizes process control tools [sampling/testing guidelines] to evaluate conformance to these standards, while actively engaging Packaging personnel. Assists in the execution of product & process change activities & process improvements focused on reducing costs, improving quality, and customer satisfaction. Employee works under minimal supervision.

Essential Functions & Accountabilities:

• Performs audits as directed by management that include, but are not limited to: 
  • a. DHR (device history record) review, product label and package review which includes responsibility for product release 
  • b. Process audits to verify conformance within established quality standards, including: advising, and working with, leadership on possible improvements. 
• Reports [to management] deviations from established procedures or product standards. 
• Participates in problem solving with management, and through direct interaction with Packaging and Distribution staff. 
• Assists in process development, performing approved protocols, validations, and qualifications through direction from leadership. 
• Capable of performing machine verification audits to packaging lines and reporting the information accurately on required forms per SOP (standard operating procedure) guidelines. 
• Assists in internal audits including audits of: department’s procedures, processes and training records. 
• Assists leadership in establishment of product defect criteria. 
• May train or assist in training of new employees and/or perform audits on trainees to provide feedback to leadership on training progress. 
• Continuously challenges the process as part of CooperVision’s Continuous Improvement culture. 
• Maintains department supplies.
• Maintains training/updates ETRs/communicates with auditing team for new training requirements.
• Maintains retention/shipments of DMRs with/to Iron Mountain.
• Assist with DMR retrieval during external audits.
• Immediately respond to internal lot block requests, ensure product is systemically blocked. Unblock product once approved disposition received.
• Aids in the disposition of nonconforming product.
• Performs other duties as assigned. 
• As business needs dictate, works extended hours to complete daily department goals or tasks to include mandatory overtime.
• Responsible for any other duties as assigned.

Travel: 

Traveling will not be required for this role. 

Knowledge, Skills and Abilities:

• Adheres to Standard Operating Procedures and Regulatory requirements.
• Exhibits good communication skills – verbal, written, and comprehension of the English language. 
• Ability to work independently as well as in a team environment.
• Must possess a high level of attention to detail and accuracy.
• Basic coursework in mathematics.
• Must be PC literate, including Microsoft Office Suite.
• Must maintain an ongoing understanding of current QA (quality assurance) procedures.
•  Ability to operate a pallet jack.

Work Environment:

• Normal Warehouse Conditions: 
• Noisy conditions - 50-75% 
• Hot or humid conditions - >75% 
• Exposure to extreme seasonal temperatures - >75% 
• Work near moving mechanical parts - >75% 
• Physical Demands:
• Standing - 25-50%
• Sitting - 50-75% 
• Walking - 25-50%
• Bending - 75% 
• Finger/wrist dexterity - >75% 
• Grasping/Pinching - 75% 
• Lifting (up to 25 lbs.) 

Experien