QA Lead: MDR & Packaging Audits

Regulatory Jobs; Town of Henrietta (NY); On-site; USD 28,000 - 32,000; Full time

Job summary

CooperVision in Henrietta, NY seeks a Quality Assurance professional to coordinate daily QA activities within an FDA-regulated environment, ensuring compliance with QSR and CooperVision standards. You will train staff, audit processes, and support continuous improvement.

You will participate in MDR projects, maintain NPV logs, and issue NCRs for nonconformances, collaborating across functions to meet production and quality targets.

Qualifications

• Minimum 3 years in a Quality Assurance environment required.
• 2 years of related experience in a packaging/distribution environment preferred.
• Knowledge of SPC (statistical process control) preferred.
• Previous leadership experience preferred.
• Previous experience in an FDA regulated environment a plus.

Responsibilities

• Coordinate day-to-day QA activities in an FDA regulated environment.
• Support MDR-related project meetings and NPVs, providing updates and tracking actions.
• Develop and maintain an NPV tracking log to document verifications.
• Initiate and process NCRs for failed NPVs with proper investigation and follow-up.
• Work cross-functionally with the MDR team and QA staff to ensure compliance.

Skills

QA audits

Regulatory compliance

Documentation review

MDR knowledge

Cross-functional collaboration

Education

High School Diploma

Tools

ERP

Agile

Microsoft Office

Job description

CooperVision in Henrietta, NY seeks a Quality Assurance professional to coordinate daily QA activities within an FDA-regulated environment, ensuring compliance with QSR and CooperVision standards. You will train staff, audit processes, and support continuous improvement.

You will participate in MDR projects, maintain NPV logs, and issue NCRs for nonconformances, collaborating across functions to meet production and quality targets.