Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics.

The Contract Manufacturing Organization (CMO) Quality Specialist position will ensure quality in the day to day activities of the manufacturing organizations of our electro mechanical devices. It will ensure products meets established quality standards throughout the manufacturing process. The position will also provide direct support to Quality Management/Quality Engineering personnel regarding operation of the department and Quality System. It will provide support to other departmental activities as directed.This position performs a wide array of activities related to: Manufacturing Support, Change Control, Nonconformance Records (NCR), Corrective and Preventive Action (CAPA), Product Surveillance, New Markets and Risk Management. Manufacturing Support, will include but not limited to: monitoring and improving first pass yield, analyzing sources of and reducing scrap, analyzing sources of quality issues and prompt resolution. The position will ensure the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations and recommend where corrections or improvements are indicated.

• Quality and Manufacturing Operations Coordinate teams to solve manufacturing quality problems in a timely fashion. For example. Analyze scrap data and identity methods of reduction. Review yield data and recommend process improvements to increase it. Review process flow to identify sources of inefficiencies and methods to improve through put. Act as a liaison between quality and contract manufacturing departments. Initiate and/or support the development of protocols and final reports for manufacturing or other quality control projects. Support manufacturing needs by ensuring proper testing is in place for raw materials, finished goods, validation, in-process material and final products is completed accurately, timely and documented correctly.
• Quality Test Data-Metrics Support manufacturing investigations and implement corrective and preventive actions, to improve product quality. Analyze quality data and identify areas for improvement
• Quality System Support Support other Quality System functions as assigned by Quality Management that are related to documentation review, equipment calibration, nonconformance review, Out of Specification (OOS), Corrective and Preventative Actions, product complaint investigations (if applicable), audits, and other tasks as directed.
• Audit Support Participate with federal, state, and local regulatory officials during regulatory inspections. Support internal and vendor quality system audits.
• Adherence to regulations Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of medical devices.
• Other duties as assigned Provides support to Quality Management and Engineering personnel and perform other duties as assigned.

• Knowledge of quality requirements for medical device / pharmaceutical organization.
• Quality experience may include quality testing (electrical systems), QA/Regulatory, and/or Validation.
• Experience with Statistical Analysis of Data.
• Experience with Statistical Sampling requirements for Process Validation.
• Knowledge of quality systems, quality techniques, current regulatory requirements and technical issues resolution.
• Ability to prepare testing protocols and reports, operating documents and procedures
• Ability to work with minimal supervision and to make effective decisions for issues of a diverse and complex scope when required.
• Computer skills in Microsoft Word, Excel, PowerPoint, Visio; Adobe; and Quality System Management Software.
• Experience in root cause analysis tools, CAPA, NCR, SCAR investigations.
• Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations.
• Familiarity with cGMP regulations and FDA/USP/EP/BP/ICH guidelines.
• Technical writing skills.
• Highly effective communication skills. Ability to work with company staff and communicate effectively throughout the organization.
• Manage multiple priorities and work with interruptions.
• Demonstrated history of teamwork and cross functional collaboration.

Benefits

• Comprehensive Medical, Dental, and Vision plan
• 20 days of Paid Time Off
• 15 paid holidays
• Paid Sick Leave
• Paid Parental Leave
• 401(k)
• Employee bonuses
• And more!

Your benefits and PTO start the date you're hired with no waiting period!
Come join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employees!