Senior Change Control Specialist – Medical Devices

Nissha Medical Technologies; Buffalo (NY); In loco; USD 63.000 - 75.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, dental, and vision coverage

401(k) with company match

Paid time off

Life and disability insurance

Professional development opportunities

Descrizione del lavoro

Nissha Medical Technologies in Buffalo, NY is seeking a Change Control Specialist III to join the Quality team. You will drive the ECR process, coordinate with Quality, Engineering, Manufacturing, Marketing, Purchasing, and Tech Services, and manage deviations and master device records.

Responsibilities include approving artwork proofs, maintaining documentation, updating drawings and specifications, and supporting multiple departments to ensure compliant product changes.

Competenze

• Minimum Associate degree; Bachelor's degree preferred.
• Experience with Microsoft Office and Oracle preferred.

Mansioni

• Facilitates the Engineering Change Request (ECR) process owned by Quality.
• Ensures requirements are reviewed by stakeholders in Quality, Engineering, Manufacturing, Marketing, Purchasing, and Tech Services.
• Coordinates actions with Marketing, Sales, Pre-Press, Purchasing, Materials Management, and Quality Control before ECR implementation.
• Provides ECR numbers, prepares ECRs, and routes them for signatures.
• Identifies deviations from procedures, drawings, specifications, and work instructions and creates Deviations as needed.
• Manages ECR and Deviation Logs; maintains Master Device Records.
• Approves artwork proofs from vendors and first-piece incoming artwork for labels and packaging components.
• Sends artwork proofs and ECRs to customers through Customer Service or Product Manager.
• Maintains packaging drawings and label artwork books; updates electrode and packaging drawings for minor changes.
• Creates/updates specifications and IIRs; maintains current specification files.
• Provides internal product detail support and coordinates resolution of specification record discrepancies.
• Manages projects and updates work instructions, forms, and OPs.

Conoscenze

Excellent communication skills

Detail oriented

Self-motivated

Good math skills

Formazione

Associate degree

Bachelor's degree preferred

Strumenti

Microsoft Office

Oracle

Descrizione del lavoro

Nissha Medical Technologies in Buffalo, NY is seeking a Change Control Specialist III to join the Quality team. You will drive the ECR process, coordinate with Quality, Engineering, Manufacturing, Marketing, Purchasing, and Tech Services, and manage deviations and master device records.

Responsibilities include approving artwork proofs, maintaining documentation, updating drawings and specifications, and supporting multiple departments to ensure compliant product changes.