Quality Assurance Specialist

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:

To work as team lead for releasing labels, cartons & leaflets by performing appropriate inspection and testing to ensure defined specifications have been met and/or checking that appropriate testing has been performed. Collaborating closely with suppliers to manage nonconformances and investigation corrective and preventative actions. To function as the Subject Matter Expert within the QA Materials Team, in relation to the suitability, correctness and release of Materials used in the packaging and labelling processes. To help in the training of other QA team members.

Knowledge, Skills, and Abilities:

• An understanding of Quality Assurance and familiarity with ISO 13485 and / or ISO 9001
• Ability to work individually or part of a team, being adaptable and an initiative-taker.
• Knowledge of Agile, Baan, Vision Pack and Blue Yonder is advantageous.
• Working knowledge of Microsoft office packages (Word, Excel, PowerPoint, Visio, Outlook).
• Motivated with good interpersonal and written communication skills to communicate effectively with all levels within the quality department as well as cross functionally within departments at CooperVision packaging and distribution sites.
• Enquiring, methodical and organised.
• Adaptable, conscientious initiative-taker.
• Impartial and objective.
• Attention to detail. Capable of decision making.
• Good eyesight and no colour-blindness

Work Environment:

• To work in a warehouse/ production/office environment, time will be split between office and warehouse / factory.
• Use of computer systems.
• The job may require working around large pallets.

Experience:

• Bachelor's degree preferred.
• 3 years QA experience.
• Experience in Quality systems such as, ISO13485, FDA, CFR 21, Part 820.

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 $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 and modification in the future. This position may also be eligible for other types of compensation and benefits.

• Receipt of Materials and respective paperwork from Stores
• Analysis of Certificates to determine which testing procedures are required.
• Conduct material inspection in accordance with documented test / inspection procedures.
• Enter details of all stock received into Excel, Blue Yonder, Baan systems (creating a traceable record for every item received).
• Raise corrective actions for non-conforming materials.
• QFB Investigations.
• Raising deviations.
• Review Color Standard & approval/rejection.
• Archiving of documentation
• Supplier Non-Conformances and advisories.
• Problem solving
• Vision Pack review of new/updated vendor proofs Vs CV artwork.
• Approval of Supplier color standards
• Monthly KPI data creation & analysis
• Controlling shelf-life stock.
• Work with the QA auditor team in providing continual cover for the release of product from the label and carton process.
• Develop, implement, and improve incoming inspection process, including procurement, calibration, and maintenance of applicable tooling.

General

• Maintaining GMP awareness within West Henrietta and ensuring compliance to documented procedures
• Training others within the QA Team, to ensure its effective operation.
• Taking the lead within the Materials Team in the absence of the Quality Assurance Engineer in all matters relating to Materials / Suppliers.
• To act as the Subject Matter Expert within the QA Materials Team, in relation to the suitability, correctness and release of Materials used in the packaging and labelling processes within West Henrietta Packaging and Distribution, and any affected CooperVision Sites.
• Promote an Audit ready mind-set within the Materials Team, ensuring compliance with all relevant CooperVision procedures and policies.
• To perform trend analysis / monthly reporting as directed by QA management.
• Perform investigations where there are concerns regarding product integrity.
• Assist in New Product Introduction activities / trials for new Materials; Assist in any Supplier Meetings or Audits as required.
• Any other duties as directed by QA management.

Travel Requirements:

• There is potential to travel to suppliers for a press pass, experience in their process or to be part of the audit team.
• Receipt of Materials and respective paperwork from Stores
• Analysis of Certificates to determine which testing procedures are required.
• Conduct material inspection in accordance with documented test / inspection procedures.
• Enter details of all stock received into Excel, Blue Yonder, Baan systems (creating a traceable record for every item received).
• Raise corrective actions for non-conforming materials.
• QFB Investigations.
• Raising deviations.
• Review Color Standard & approval/rejection.
• Archiving of documentation
• Supplier Non-Conformances and advisories.
• Problem solving
• Vision Pack review of new/updated vendor proofs Vs CV artwork.
• Approval of Supplier color standards
• Monthly KPI data creation & analysis
• Controlling shelf-life stock.
• Work with the QA auditor team in providing continual cover for the release of product from the label and carton process.
• Develop, implement, and improve incoming inspection process, including procurement, calibration, and maintenance of applicable tooling.

General

• Maintaining GMP awareness within West Henrietta and ensuring compliance to documented procedures
• Training others within the QA Team, to ensure its effective operation.
• Taking the lead within the Materials Team in the absence of the Quality Assurance Engineer in all matters relating to Materials / Suppliers.
• To act as the Subject Matter Expert within the QA Materials Team, in relation to the suitability, correctness and release of Materials used in the packaging and labelling processes within West Henrietta Packaging and Distribution, and any affected CooperVision Sites.
• Promote an Audit ready mind-set within the Materials Team, ensuring compliance with all relevant CooperVision procedures and policies.
• To perform trend analysis / monthly reporting as directed by QA management.
• Perform investigations where there are concerns regarding product integrity.
• Assist in New Product Introduction activities / trials for new Materials; Assist in any Supplier Meetings or Audits as required.
• Any other duties as directed by QA management.

Travel Requirements:

• There is potential to travel to suppliers for a press pass, experience in their process or to be part of the audit team.