QA Materials Release Technician

CooperCompanies•Henrietta, NY

4d•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 is responsible for quarantining materials, conducting inspections, and determining disposition. It also involves contacting suppliers about delivery issues and sending non-conformance reports (NCRs) and samples when appropriate, including in the QA Materials Supervisor’s absence. The technician supports incoming inspection and quality auditing activities, documents results, helps identify and remove nonconforming components, and contributes to the maintenance of procedures and quality standards. The role works with internal departments, suppliers, and CooperVision sites and may travel to suppliers for process experience or as part of an audit team. This is a full-time, onsite position five days per week in Victor, New York. It is not eligible for relocation assistance or employer-sponsored work authorization.

Requirements

High school diploma or GED.
Basic coursework in mathematics and PC and business understanding, or equivalent training and/or experience.
Basic computer skills necessary for packaging software.
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 Office packages, including Word, Excel, PowerPoint, Visio, and Outlook.
Knowledge of SPC (statistical process control).
Ability to use Agile, a product lifecycle management tool.
Ability to operate various types of manual and/or electric pallet jacks.
Ability and dexterity to handle small items.
Good eyesight and no color blindness.
Strong attention to detail and accuracy; methodical, organizational, and decision-making skills; and an impartial and objective approach.
Good interpersonal, written, verbal, and English comprehension skills, with the ability to communicate across the quality department and cross-functionally.
Ability to work independently and as part of a team, demonstrate effective leadership skills, and adapt to changing workload, priorities, staffing, and scheduling.
Ability to multitask in a fast-paced environment and adhere to standard operating procedures and regulatory requirements.

Nice To Haves

Knowledge of Agile, Baan, JDA, and VisionPack.
Two years of manufacturing or machine operation experience.

Responsibilities

Review, approve, or reject new or updated artwork in VisionPack.
Confirm receipt of components and their associated paperwork.
Analyze required certificates to determine which testing procedures are required.
Inspect incoming component pallets for damage, verify counts, and collect audit samples.
Perform incoming inspections in accordance with documented test and inspection procedures, and record the results.
Assist supporting departments in identifying and separating conforming components from nonconforming inventory.
Help quantify and segregate nonconforming components and ensure they are systematically removed to prevent future use.
Create non-conformance reports (NCRs) when applicable and contact suppliers about delivery issues or NCRs as appropriate.
Collect, file, and maintain supplier shipment documents, approval sheets, and other paperwork.
Update standard operating procedures and create deviations related to the incoming inspection process.
Support the QA Auditing team with re-audits of nonconforming finished goods and perform audits as directed, including DHR and product label or package reviews.
Assist with process audits, advise managers and supervisors on possible improvements, and help verify conformance to quality standards.
Fill in for day-to-day audit activities as needed.
Monitor and enforce compliance with external regulations and CooperVision quality standards, and report deviations from established procedures or product standards to management.
Serve as a resource to QA Auditors when interpreting component quality standards and troubleshoot or problem-solve as needed.
Review specifications to ensure 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 in training new employees and audit trainees to provide feedback on their progress.
Challenge processes as part of CooperVision’s continuous improvement culture.
Support the supervisor or management on department performance and processes and provide backup in their absence.
Follow quality requirements, SOPs, work instructions, company policies, and safety guidelines; meet established standards and maintain a clean working environment.
Perform other duties as assigned or required.