QA Materials Release Technician

CooperCompanies•West Henrietta, NY

4d•$23 - $28•Onsite

About The Position

The QA Materials Release Technician inspects incoming raw materials and packaging components, including blister labels, cartons, leaflets (IFUs), and overlabels. The role includes quarantining materials, determining disposition, reviewing paperwork and certificates, sampling and inspecting components, recording results, and managing nonconforming materials. When the QA Materials Supervisor is absent, the technician may contact suppliers about delivery issues and send non-conformance reports (NCRs) and samples. The technician also supports auditing and quality activities, including audits of finished goods and processes, document reviews, internal audits, training, and process development. The role helps ensure compliance with documented procedures, Good Manufacturing Practices, regulatory requirements, and CooperVision quality standards, and contributes to continuous improvement. This is a full-time, onsite role in Victor, New York, five days per week. Relocation assistance is not available. Travel to suppliers may be required for process experience or audit-team activities.

Requirements

High school diploma or GED.
Experience with basic mathematics coursework, personal computers, and business understanding, or equivalent training or experience.
Basic computer skills for packaging software.
Ability and dexterity to handle small items.
Experience with medical device manufacturing and/or packaging in an FDA-compliant environment.
Understanding of Quality Assurance and familiarity with ISO 13485.
Working knowledge of Microsoft Word, Excel, PowerPoint, Visio, and Outlook.
Knowledge of statistical process control (SPC).
Ability to use Agile, a product lifecycle management tool.
Ability to operate manual and/or electric pallet jacks.
Good eyesight and no color blindness.
Strong attention to detail and accuracy.
Enquiring, methodical, and organizational skills; impartiality, objectivity, and decision-making ability.
Good interpersonal, written, verbal, and English comprehension skills to communicate with quality and cross-functional teams.
Ability to work independently and in a team environment while exhibiting effective leadership skills.
Ability to multitask in a fast-paced environment and adapt to changes in workload, priorities, staffing, and scheduling.
Ability to follow SOPs and regulatory requirements and encourage open communication and teamwork.
Ability to work full-time onsite five days per week in Victor, New York.
Must be authorized to work in the United States permanently and on an ongoing basis without current or future employer-sponsored work authorization.

Nice To Haves

Knowledge of Agile, Baan, JDA, and VisionPack.
Two years of manufacturing or machine operation experience.
Experience that supports potential supplier visits for process experience or participation in supplier audits.

Responsibilities

Review, approve, or reject new or updated artwork in VisionPack.
Confirm receipt of components and their associated paperwork.
Analyze required certificates to determine applicable testing procedures.
Inspect incoming component pallets for damage, verify counts, and collect audit samples.
Perform incoming inspections in accordance with documented test and inspection procedures.
Record inspection data and results.
Help identify conforming components by inspecting and culling them from inventory when nonconforming components are present.
Help quantify and segregate nonconforming components and ensure they are systematically removed to prevent future use.
Create non-conformance reports (NCRs) when applicable.
Collect, file, and maintain supplier shipment documents, approval sheets, and other paperwork.
Update standard operating procedures (SOPs) and create deviations related to incoming inspection.
Support the QA Auditing team with re-audits of nonconforming finished goods.
Perform management-directed audits, including document history record (DHR) reviews and product label or package reviews.
Assist with process audits to verify conformance with established quality standards and work with managers and supervisors on possible improvements.
Fill in for day-to-day audit activities as needed.
Monitor and enforce compliance with external regulations and CooperVision quality standards.
Report deviations from established procedures or product standards to management.
Serve as a resource to QA Auditors when interpreting component quality standards.
Troubleshoot and solve problems as needed.
Review specifications to verify that procedures and product quality have been maintained.
Assist with process development and perform approved protocols, validations, and qualifications under leadership direction.
Assist with internal audits of department procedures, processes, and training records.
Assist leadership in establishing product defect criteria.
Train or assist with training new employees and audit trainees to provide feedback on progress.
Contribute to continuous improvement by challenging existing processes.
Support supervisors and management with department performance and processes and serve as a backup in their absence.
Follow quality requirements, SOPs, work instructions, company and department policies, safety guidelines, and Good Manufacturing Practices.
Maintain a clean working environment and meet established standards.
Perform other duties as assigned or required.