Quality Assurance Coordinator (Days- 1 Year- Contract)

CooperCompanies•Henrietta, NY

4d•Onsite

About The Position

With general guidance and minimal supervision, the Quality Assurance Coordinator organizes and coordinates the day-to-day activities of the Quality Assurance department. The role audits packaging and distribution materials, goods, and activities in an FDA-regulated environment to ensure compliance with external regulations and CooperVision quality standards. The position is full-time and onsite five days per week in Henrietta, New York, and is a one-year contract. It is not eligible for relocation assistance or employer-sponsored work authorization now or in the future; applicants must be authorized to work permanently in the United States without future sponsorship. The coordinator supports Medical Device Regulation (MDR) work, conducts and documents New Product Verifications (NPVs), initiates reports for failed verifications, and works cross-functionally with the MDR team. The role also helps maintain quality systems, review documents, support process development and internal audits, train employees, and provide day-to-day support to auditors and department leadership. Mandatory overtime and extended hours may be required as business needs dictate. Travel is not required.

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 and written communication skills and comprehension of English.
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 product lifecycle management and ERP tools.
Ability to operate a pallet jack.

Nice To Haves

At least 2 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 deliverables are completed on time.
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 recurring causes of successes and failures.
Initiate and process Nonconformance Reports (NCRs) for failed NPVs, ensuring documentation, investigation, and follow-up.
Work cross-functionally with the MDR team.
Coordinate daily QA department activities, including prioritizing and organizing auditors’ workflow.
Monitor and enforce compliance with Quality System Regulations (QSR), and report deviations from established procedures or product standards to management.
Serve as a resource for QA Auditors interpreting quality standards; troubleshoot and solve problems as needed.
Review specifications to ensure procedures and product quality are 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 SOPs, and take responsibility for product release.
Assist with internal audits of department procedures, processes, and training records, and support approved protocols, validations, and qualifications.
Assist leadership in establishing product defect criteria.
Train or assist with training new employees, audit trainees, and provide leadership with feedback on training progress.
Fill in for day-to-day audit activities as needed.
Challenge processes as part of the continuous improvement culture.
Support supervisors and management with department performance and processes, and provide backup in their absence.
Work extended hours and mandatory overtime when business needs require completion of daily department goals or tasks.
Perform other duties as assigned.