CNOC Management Specialist

Position Summary

The Customer Notification of Change (CNOC) Management Specialist is responsible for performing tasks that drive the timely review and notification of changes to customers, external and sister facilities, for the OEM BU. This position will evaluate, and process change notifications from each facility, review change notifications for completeness and adherence to procedures and ensure timely distribution and notification. This position directly contributes to the efficiency of end-to-end operations by building and maintaining strong cross-functional relationships and by using critical thinking to identify and understand complex problems and leading efforts to implement appropriate solutions.

Principal Responsibilities

• Subject matter expert in Customer Notification of Change process
• Facilitate the timely review, approval, and release of notification letters and data
• Support development of new documentation and provide detailed reports, queries, or summaries
• Assist in monitoring process effectiveness, including the impact of changes, and recommend process improvements
• Utilize visual management and participate in problem solving, metric reporting/improvement, and other various projects, as assigned
• Apply best practices in change control, configuration management, and continuous improvements
• Provide high-level customer service and support to specific cross-functional areas
• Provide training support, as requested
• Key point of contact for OEM sites and Sales Team in regard to Customer Notifications
• Other duties as assigned.

Education / Experience Requirements

• Bachelors Degree preferred. With Bachelors degree, minimum 2 years of experience in medical device industry, required.
• Without Bachelors degree or with Associates Degree, minimum 5 years of experience in medical device industry required.
• A minimum of 2 years relevant experience with quality systems, technical writing, and change control requirements in a regulated industry
• Broad functional expertise in change control management
• Knowledge of Quality System requirements (ISO 13485, CFR 820, etc.)

Specialized Skills / Other Requirements

• Excellent written and oral communication skills
• Detail oriented and self-directed with excellent time management skills
• Technical writing skills preferred
• Experience with PLM and ERP software, database management.
• Proficient with Microsoft Office Suite (Word, Excel, Project, PowerPoint)
• Ability to effectively execute projects and related activities with appropriate priority required
• Excellent critical thinking skills & ability to identify and solve problems of moderate scope & complexity
• Ability to mentor and advise cross-functional teams in resolving intermediate to complex problems
• Ability to function as part of a team and achieve results through open collaboration with others
• Results oriented with the ability to be accountable to the achievement of both individual and team goals

Working Conditions / Physical Demands

• Ability to sit, stand, and walk throughout the day as needed in an office and light manufacturing/assembly environment to perform tasks
• Fine and gross motor skills to perform tasks using measurement equipment and standard office equipment, including frequent keyboarding, computers, peripherals, phones, and other devices as required
• Ability to communicate clearly both in writing and using spoken communication, with or without assistance
• Ability to read, comprehend, and appropriately act upon detailed written information at an advanced level, with or without assistance
• Infrequent lifting of up to 20 pounds may be required

The pay range for this position at commencement of employment is expected to be between $85,000 - $95,000 however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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