Quality Management Systems Specialist

CooperVision, Inc.; Victor (ID); Sur place; USD 70 000 - 90 000; Plein temps

Résumé du poste

CooperVision, Inc. is seeking a Quality Management System Specialist to lead QA activities at the Victor site, ensuring compliance with global and local requirements.

The role focuses on QA records, problem reports, change orders, CAPA/NCR, and supporting SOPs, WI's, and training. This onsite role interacts with cross-functional teams and uses eQMS for document processing.

Qualifications

• QA activities with local and global departments.
• Lead QA analyst for quality records, problem reports, change orders.
• Experience with audits and CAPA/NCR processes.

Responsabilités

• Act as lead QA analyst for quality records and problem reports.
• Support change control, document control, and SOP maintenance.
• Collaborate with global and local teams on QA processes.

Connaissances

Quality Assurance

QA Lead

CAPA NCR

Document control

eQMS

Auditing

Interdepartmental collaboration

Outils

eQMS

Change control

Description du poste

At CooperVision , a business unit of CooperCompanies (Nasdaq: COO), we're driven by a unified purpose of helping people 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

• This role is not eligible for employer-sponsored work authorization now or in the future. Applicants must be authorized to work in the United States on a permanent and ongoing basis without the need for future sponsorship (i.e., H1B, STEM OPT extensions, TN, etc.)
• This position requires full-time onsite work (5 days per week) in Victor, NY and is not eligible for relocation assistance.

Scope

This position covers a wide breadth of the quality system including New Product Launch, Packaging, Documents, Specifications, Validations, Training, Auditing, etc. Acts as the Quality Assurance lead in many of our cross functional projects/teams and requires independent decision making to help define and develop the global processes for CooperVision. Interaction primarily with global departments and local departments within Victor as well as other Secondary Packaging and Distribution sites. This role is responsible for performing a detailed QA review of 4000+ quality records annually. Any discrepancy, nonconformance or investigation required for these records is within the scope of responsibility for the Quality Management System Specialist.

Essential Functions & Accountabilities

Responsible for conducting required Quality Assurance activities with local (Rochester) and global departments. Act as the lead Quality Analyst for quality records, problem reports, change orders and other quality processes. Support Document Control Specialists in the maintenance of Packaging and Labeling QMS data and ensuring CooperVision compliance to change control requirements for global processes. Oversight of cross-functional teams that provide input to the related processes.

Work with key business stakeholders through change order and problem report processes. Acts as site lead for a variety of problem reports (CAPA/NCR/etc.), ensuring timely movement through the process while safeguarding compliance. Involvement with internal auditing for local CooperVision sites.

Will revise and at times create Standard Operating Procedures (SOP's), Work Instructions (WI's) and ther controlled documents in collaboration with process owners and subject matter experts. Will utilize the electronic Quality Management System (eQMS) to process these documents and obtain approvals as well as review Change Orders and support training. Participation with establishing procedures for Global review of change packages as well as engineering changes, engineering, studies, and validations when necessary.