Quality Management Systems Specialist

CooperVision, a business unit of CooperCompanies and a global manufacturer of contact lenses, is seeking a Quality Management Systems Specialist. The role leads and performs quality assurance activities across quality records, change control, document control, audits, CAPA/NCR processes, training, validations, and continuous improvement initiatives.

Responsibilities

Acts as the Quality Assurance representative and participates with cross functional teams on significant Packaging and Labeling projects (example. mass change for regulation update)

Acts as the QA approver and change analyst for a variety of change orders (ECO, DCO, NPLCO, DRCO, and PCO)

Provides guidance and is the QA lead on process requirements to ensure compliance with change control regulations and CooperVision policies and procedures

SME for Quality Assurance in associated Global Processes

Acts as final QA review prior to execution of changes where required. Responsible for ensuring all requirements are met prior to final release

Lead in continuous improvement efforts to streamline the QA review in above mentioned processes

Acts as change analyst for Document Change Orders (DCO’s) and any required Deviations for functional departments residing under the CooperVision QMS at the site

Manages Training positions and roles in Agile for functional departments residing under the CooperVision QMS at the site

Reviews and participates in implementation of global document changes document required for the site and globally

Regularly provides status and updates to QA Management regarding state of QMS data and continuous improvement projects

Communicates information effectively to and from other departments with the QA team

Investigation, lead, coordinate, reviews and approvals of corrective and preventative action (CAPA) and nonconformance’s (NCR)

Assists with internal and process audits to verify conformance with standard operating procedures. This will include revising and or creating SOPs as needed. Conducts internal audits in any of the Rochester facility as required

Data entry and analysis into computer-based collection systems as required (Access, Excel & eQMS)

Performs archiving (as necessary) as it applies to quality records for the site. May assist in all aspects of record retention and retrieval. May act as Administrator for record retention activities

Provides eQMS and required QSR training for employees at the site. Applies knowledge of Good Manufacturing Practices (GMP) regulations and industry standards as well as ISO general guidelines

Performs other assignments related to the department as directed by Leadership

Preferred

Experience with Agile preferred

Lead auditor experience preferred

Medical Device industry experience preferred

Agile

Lead Auditor Experience

Medical Device Industry Experience

Company

Global medical device company for contact lenses and fertility care

San Ramon, California, USA

http://www.coopercos.com/

Founded in 1958

10001+ employees

Qualifications

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.)

Excellent written, oral, and interpersonal communication skills

Highly self-motivated, self-directed and attentive to detail

Well organized and detail oriented, strong data entry and analysis

Highly adaptable, flexible and willing to accept new ideas, processes and procedures

Excellent analytical and problem-solving skills, with strong attention to detail. Ability to drive to root cause

Ability to effectively prioritize and execute tasks, and meet project deadlines in a fast-paced environment

Working knowledge of Microsoft Office Suite

Possesses skills to utilize the concept of continuous improvement, change management and employee teams. Ability to work with a diverse workforce

Knowledge of Quality Assurance regulations and methodologies, including Good Documentation Practices. Ability to enforce standards (QSR, CVI, etc.) and standardize global processes

2-3 years of experience with Quality Assurance required

Bachelor's degree required in related field; or an equivalent combination of education and experience is required

Experience with Agile preferred

Lead auditor experience preferred

Medical Device industry experience preferred

Required skills

Quality Assurance, Quality Management Systems (QMS), Change Management, Corrective and Preventive Action (CAPA), Nonconformance (NCR) Management, Internal Auditing, Standard Operating Procedures (SOPs), Manufacturing Practices (GMP), Quality System Regulation (QSR), Microsoft Office Suite, Agile

Preferred skills

Experience with Agile preferred, Lead auditor experience preferred, Medical Device industry experience preferred, San Ramon, California, USA, http://www.coopercos.com/, Public Company, Total Funding, $1.5B, Key Investors, JANA Partners, 2025-10-19, Post Ipo Equity, 2023-09-26, IPO, 2021-12-17, Post Ipo Equity· $1.5B, Leadership Team, Agostino Ricupati, SVP Finance - Tax and Chief Accounting Officer, Recent News, Newsfile, 2026-09-30, StreetInsider.com, 2026-09-28, PR Newswire, 2026-09-24, Company data provided by, AI Tools, Customize Your Resume, Maximize your interview chances

Experience

2-3 years