Quality Management Systems Specialist

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.

• 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.  Experience with Agile preferred
• 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

Experience:   

•    2-3 years of experience with Quality Assurance required
•    Lead auditor experience preferred 
•    Medical Device industry experience preferred

Education:    

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

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 $58,412.00 and $77,882.00 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.

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• 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