Quality Management Systems Specialist (Medical Devices)

Location: Full-time onsite work five days per week in Victor, New York, United States. Not eligible for relocation assistance.

Salary: $58,412–$77,882 per year in base pay.

Company

hirify.global is a global manufacturer of contact lenses and a business unit of CooperCompanies, developing products for vision conditions including astigmatism, presbyopia, and childhood myopia.

What you will do

• Lead quality assurance activities for quality records, problem reports, change orders, packaging, labeling, and other QMS processes.
• Review more than 4,000 quality records annually and manage discrepancies, nonconformances, and investigations.
• Act as QA representative, approver, and change analyst for cross-functional packaging, labeling, engineering, and new product launch projects.
• Lead and coordinate CAPA, NCR, deviation, and problem-report activities through timely resolution and final QA review.
• Create and revise SOPs, work instructions, and controlled documents using the electronic QMS.
• Support internal audits, employee training, record retention, data analysis, and continuous improvement initiatives.

Requirements

• Permanent authorization to work in the United States without current or future employer sponsorship is required.
• Ability to work onsite in Victor, NY five days per week is required.
• 2–3 years of Quality Assurance experience.
• Bachelor’s degree in a related field, or an equivalent combination of education and experience.
• Knowledge of Quality Assurance regulations and methodologies, Good Documentation Practices, QSR, GMP, ISO guidelines, and global process standardization.
• Strong communication, analytical, problem-solving, organizational, prioritization, and data-entry skills; working knowledge of Microsoft Office Suite.

Nice to have

• Lead auditor experience.
• Medical device industry experience.
• Experience with Agile.

Culture & Benefits

• Work with global and local departments, cross-functional teams, and secondary packaging and distribution sites.
• Participate in projects focused on continuous improvement and global process development.
• Work in an environment emphasizing dedication, innovation, partnership, friendliness, and ethical decision-making.
• Equal employment opportunity workplace.