Quality Assurance Coordinator (Days- 1 Year- Contract)

CooperCompanies•West Henrietta, NY

4d•$20 - $23•Onsite

About The Position

With general guidance and minimal supervision, the Quality Assurance Coordinator coordinates the day-to-day activities of the Quality Assurance department. The role includes auditing Packaging and Distribution materials, goods, and activities in an FDA-regulated environment to ensure conformance with external regulations and CooperVision quality standards. The coordinator also trains or assists with training new employees, audits trainees, and communicates their progress to leadership. The position supports Medical Device Regulation (MDR) work, including project meetings and New Product Verifications (NPVs), and coordinates auditor workflow. It helps maintain compliance with Quality System Regulations, supports documentation review and internal audits, contributes to process development and continuous improvement, and serves as a resource to QA auditors. The role may provide backup support to the supervisor or management when needed. This is a one-year contract requiring full-time onsite work five days per week in Henrietta, New York. Travel is not required. Work takes place under normal warehouse conditions, including noise, heat or humidity, seasonal temperature extremes, and proximity to moving mechanical parts. Mandatory overtime may be required as business needs dictate. The position is not eligible for employer-sponsored work authorization or relocation assistance.

Requirements

At least 3 years of experience in a Quality Assurance environment.
High school diploma or GED.
Ability to adhere to Standard Operating Procedures and regulatory requirements.
Good verbal, written, and English comprehension skills.
Ability to encourage open communication and a team atmosphere.
Ability to work independently and as part of a team, with effective leadership skills.
High attention to detail and accuracy.
Basic mathematics coursework.
PC literacy, including Microsoft Office Suite.
Ability to use Agile and ERP tools.
Ability to operate a pallet jack.
Authorization to work in the United States permanently and on an ongoing basis without current or future employer-sponsored work authorization.
Ability to work full-time onsite five days per week in Henrietta, NY.

Nice To Haves

Two years of related experience in a packaging or distribution environment.
Knowledge of statistical process control (SPC).
Previous leadership experience.
Previous experience in an FDA-regulated environment.

Responsibilities

Support and participate in MDR project meetings by providing updates, tracking action items, and ensuring timely completion of deliverables.
Perform routine and project-related New Product Verifications (NPVs) in support of MDR requirements and business operations.
Develop and maintain an NPV tracking log documenting completed verifications and identifying recurring causes of success and failure.
Initiate and process Nonconformance Reports (NCRs) for failed NPVs, ensuring accurate documentation, investigation, and follow-up.
Work cross-functionally with the MDR team.
Coordinate daily QA department activities, including prioritizing and organizing auditor workflow.
Monitor and enforce compliance with Quality System Regulations (QSR).
Report deviations from established procedures or product standards to management.
Serve as a resource to QA auditors interpreting quality standards.
Troubleshoot and solve problems as needed.
Review specifications to ensure procedures and product quality have been maintained.
Assist with process development and perform approved protocols, validations, and qualifications as directed by leadership.
Update standard operating procedures (SOPs) and create deviations.
Create NCRs and audit reworked nonconformances.
Perform verification audits on packaging lines, accurately report results on required forms according to SOP guidelines, and take responsibility for product release.
Assist with internal audits of departmental procedures, processes, and training records, supporting approved protocols, validations, and qualifications.
Assist leadership in establishing product defect criteria.
Train or assist in training new employees and audit trainees, providing leadership with feedback on training progress.
Fill in for day-to-day audit activities as needed.
Challenge processes as part of the company’s continuous improvement culture.
Support the supervisor or management regarding departmental performance and processes, and provide backup in their absence.
Perform other duties as assigned.
Work extended hours, including mandatory overtime, when business needs require it to complete department goals or tasks.