Change Control Specialist III

About Nissha Medical Technologies

What You Will Do

• Nissha Medical Technologies is looking for a Change Control Specialist III to join our Quality team in Buffalo, NY! This position Facilitates the Engineering Change Request (ECR) process owned by the Quality Department. Ensures that all necessary requirements are completed/ reviewed by stakeholders in Quality, Engineering, Manufacturing, Marketing, Purchasing, and Tech Services prior to implementation of ECRs. Ensures that the ECR moves through the stages in a timely fashion.
• Facilitates all new and revised medical device product and component specifications through ECRs. Coordinates required actions with Marketing, Sales, Pre-Press, Purchasing, Materials Management, and Quality Control prior to implementation of any ECRs.
• Provides ECR numbers, prepares ECRs, and routes them for signatures.
• Identifies deviations from current procedures, drawings, specifications, and work instructions, and creates and routes Deviations as needed.
• Manages ECR and Deviation Logs.
• Maintains Master Device Records by moving approved revisions to the active records and outdated revisions to obsolete records.
• Manages hard-copy Master Device Records, both active and obsolete.
• Maintains the Master List of all finished goods and components, including revision history, dates, controlled copies, and additional information.
• Approves artwork proofs from vendors.
• Approves first-piece incoming artwork for labels, pouches, inserts, and other components.
• Sends artwork proofs and ECRs, when required, to customers through Customer Service or the Product Manager.
• Manages controlled copies of packaging drawings and label artwork books in the packaging and labeling area.
• Updates electrode and packaging drawings for typographical errors and changes that do not require an Engineer.
• Creates and updates specifications and IIRs as needed.
• Maintains current and accurate specification files.
• Provides internal product detail support to all departments and coordinates the resolution of product specification record discrepancies.
• Manages assigned projects as needed.
• Updates work instructions (WIs), forms, and operating procedures (OPs) as requested.

What You Bring

• Core Qualifications
• Minimum Associate degree, Bachelor’s degree preferred. Experience with Microsoft Office and Oracle preferred.

Preferred Qualifications

• Excellent communication skills; both written and verbal
• Self-motivated
• Detail oriented
• Good math skills
• Experience with Microsoft Office & Oracle preferred
• Professional Traits We Value
• Excellent project management skills
• Strong leadership abilities
• Able to coordinate numerous, diverse, detailed activities concurrently
• Compensation & Benefits
• The expected salary range for this position is $63,000-$75,000. Actual compensation will be determined based on experience, skills, qualifications, and geographic location.
• In addition, Nissha Medical Technologies offers a competitive total rewards package including medical, dental, and vision coverage, 401(k) with company match, paid time off, life and disability insurance, and professional development opportunities.
• Equal Opportunity Statement
• Nissha Medical Technologies is an Equal Opportunity Employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected status under applicable law.
• Minimum Associate degree, Bachelor’s degree preferred. Experience with Microsoft Office and Oracle preferred.

Qualifications

• Core Qualifications