QA Materials Specialist

At CooperVision, a division of CooperCompanies, we’re driven by a unifying purpose to help people experience life’s beautiful moments. As a leading global manufacturer of contact lenses, we tackle the toughest vision challenges—including astigmatism, presbyopia, and childhood myopia—through our diverse lens portfolio.

About the role

To work as team lead for releasing labels, cartons, and leaflets by performing appropriate inspection and testing to ensure defined specifications have been met. Collaborate closely with suppliers to manage non-conformances and investigate corrective and preventive actions. Function as the Subject Matter Expert within the QA Materials Team for the suitability, correctness, and release of materials used in packaging and labeling processes. Assist in training other QA team members.

Responsibilities

• Receipt of materials and respective paperwork from Stores.
• Analysis of Certificates to determine required testing procedures.
• Conduct material inspection in accordance with documented test/inspection procedures.
• Enter details of all stock received into Excel, Blue Yonder, and Baan systems (creating a traceable record for every item).
• Raise corrective actions for non-conforming materials.
• Perform QFB investigations and raise deviations.
• Review Color Standards and approve/reject materials.
• Archive documentation.
• Manage supplier non-conformances and advisories.
• Problem-solving and vision pack review of new/updated vendor proofs vs. CV artwork.
• Approval of supplier color standards.
• Monthly KPI data creation and analysis.
• Control shelf-life stock.
• Work with the QA auditor team to provide continual cover for the release of product from the label and carton process.
• Develop, implement, and improve incoming inspection processes, including procurement, calibration, and maintenance of applicable tooling.
• Maintain GMP awareness within West Henrietta and ensure compliance with documented procedures.
• Train others within the QA Team to ensure effective operation.
• Act as the Subject Matter Expert for materials/suppliers in the absence of the Quality Assurance Engineer.
• Promote an audit-ready mindset within the Materials Team, ensuring compliance with CooperVision procedures and policies.
• Perform trend analysis and monthly reporting as directed by QA management.
• Investigate concerns regarding product integrity.
• Assist in New Product Introduction activities/trials for new materials.
• Participate in supplier meetings or audits as required.
• Perform any other duties as directed by QA management.

Requirements

• Bachelor’s degree preferred.
• 3 years of QA experience.
• Experience in quality systems such as ISO 13485, FDA, CFR 21, Part 820.

Skills

• Understanding of Quality Assurance and familiarity with ISO 13485 and/or ISO 9001.
• Ability to work individually or as part of a team; adaptable and initiative-taker.
• Knowledge of Agile, Baan, Vision Pack, and Blue Yonder is advantageous.
• Working knowledge of Microsoft Office (Word, Excel, PowerPoint, Visio, Outlook).
• Strong interpersonal and written communication skills.
• Methodical, organized, and detail-oriented.
• Capable of decision-making; impartial and objective.
• Good eyesight and no color-blindness.

Work Environment

Warehouse/production/office environment with time split between office and warehouse/factory. Use of computer systems and potential exposure to large pallets.

Travel Requirements

Potential travel to suppliers for press passes, process experience, or participation in audit teams.

Pay

Starting base pay for this role is between $69,550.00 and $92,733.00 per year and may include cost of living adjustments. The actual base pay includes many factors and is subject to change. This position may also be eligible for other types of compensation and benefits.