QA & Compliance Coordinator – MDR Audits (Onsite)

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

Job summary

CooperVision, a CooperCompanies business unit, is seeking a Quality Assurance professional to coordinate day-to-day QA activities in an FDA-regulated environment at our Henrietta, NY site. The role includes auditing packaging and distribution materials, training staff, and maintaining NCRs with cross-functional MDR support.

Minimum 3 years QA experience, 2 years in packaging/distribution preferred, and familiarity with SPC, Agile PLM, and ERP tools.

Qualifications

• Minimum of 3 years in a Quality Assurance environment.
• 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.
• High School Diploma or GED required.

Responsibilities

• Coordinate day-to-day QA activities in an FDA-regulated environment.
• Audit packaging and distribution materials and processes.
• Train or assist in training of new employees; supervise trainees.
• Initiate and process Nonconformance Reports (NCRs) and track resolutions.
• Collaborate cross-functionally with the MDR team and QA peers.
• Maintain an NP V tracking log and support verifications.
• Ensure compliance with Quality System Regulations (QSR).
• Assist leadership in establishing product defect criteria and process improvements.

Skills

SOP compliance

Communication skills

Team leadership

Attention to detail

Math basics

PC literacy

SPC knowledge

Agile PLM

ERP tools

Pallet jack operation

Education

High School Diploma or GED

Tools

Agile PLM

ERP software

Microsoft Office

Job description

CooperVision, a CooperCompanies business unit, is seeking a Quality Assurance professional to coordinate day-to-day QA activities in an FDA-regulated environment at our Henrietta, NY site. The role includes auditing packaging and distribution materials, training staff, and maintaining NCRs with cross-functional MDR support.

Minimum 3 years QA experience, 2 years in packaging/distribution preferred, and familiarity with SPC, Agile PLM, and ERP tools.