Change Control Specialist III

Nissha Medical Technologies; Buffalo (NY); On-site; USD 63,000 - 75,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) with company match

Paid time off

Life and disability insurance

Professional development opportunities

Job summary

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.

Qualifications

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

Responsibilities

• 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.

Skills

Excellent communication skills

Detail oriented

Self-motivated

Good math skills

Education

Associate degree

Bachelor's degree preferred

Tools

Microsoft Office

Oracle

Job description

JOB DESCRIPTION About Nissha Medical TechnologiesNissha Medical Technologies (NMT) is a global Contract Development and Manufacturing Organization (CDMO) where people, purpose, and technology come together to advance healthcare. Headquartered in the United States, NMT is the medical devices business unit and a wholly owned subsidiary of Nissha Co., Ltd., a publicly traded Japanese company based in Kyoto, Japan (TSE: 7915).Across our global organization, our teams collaborate to design and manufacture innovative medical devices and solutions that make a real difference in patients' lives. We partner closely with our customers to solve complex challenges, move ideas forward, and support products from concept through commercialization. Our work spans patient monitoring, surgical and interventional solutions, precision components, and emerging technologies, all grounded in a strong culture of quality, accountability, and continuous improvement.At Nissha Medical Technologies, we believe our success is driven by our people. We foster an environment where curiosity is encouraged, teamwork is valued, and individuals are empowered to grow their skills and careers. If you're motivated by meaningful work, collaboration, and the opportunity to help shape the future of healthcare, you'll find a place to belong at NMT.

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 verbalSelf-motivatedDetail orientedGood math skillsExperience with Microsoft Office & Oracle preferred

Professional Traits We Value

Excellent project management skillsStrong leadership abilitiesAble 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.