Associate Manager, Document Control

Merz North America, Inc.; Franksville (WI); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Medical plans

Dental

Vision

401(k)

PTO 20 days

Paid holidays 15

Job summary

Merz North America, Inc. seeks an Associate Manager, Document Control to lead the document control team and oversee creation, revision, approval and release of QMS documents.

You will ensure compliance with Merz QMS and regulatory standards, while supporting training and process improvements across the organization. Ideal candidates bring 3–5 years in quality roles within medical devices or regulated industries, plus 2+ years in a supervisory capacity, and strong communication and

Qualifications

• Bachelor's degree required in a relevant field.
• 3-5 years of quality experience in medical devices, pharmaceuticals or equivalent regulated industry.
• 2+ years of supervisor or lead experience.

Responsibilities

• Lead Document Control department and personnel to meet goals and deadlines.
• Ensure document control processes comply with global standards and regulations.
• Maintain awareness of regulatory changes and implement requirements.
• Drive continuous improvement initiatives within the Quality Systems department.
• Support internal, external and vendor audit activities.

Skills

Leadership

Quality Assurance

Regulatory knowledge

Communication

Problem-solving

Education

Bachelor's Degree

Tools

MS Word

MS Excel

PowerPoint

Visio

Access

Adobe

QMS Software

Job description

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.

A Brief Overview

The Associate Manager, Document Control is responsible for providing tactical and strategic leadership for the Document Control Specialists and the process for the review and approval for Merz QMS Documents. Day-to-day activities include coordination, management and review of the document control team and their activities. Perform and/or assist with tasks required to oversee the proper creation, revision, approval and release of documents in accordance with the Merz QMS, regulations and standards. Oversee and/or assist with tasks related to the activities associated with operation of Merz North America Inc. Quality System and as directed. Provide direct support to Quality Management/Quality Assurance personnel regarding operation of the department and Quality System. Provide support to other departmental activities as directed.

What You Will Do

• Management Manage Document Control department and personnel. Leverage the Document Control team to ensure that business goals, deadlines and performance standards are met.
• Document Control Ensure all aspects of the Document Control Function effectively and efficiently meet global standards and regulations.
• Adherence to Regulations and Standards Maintain awareness of changes to global regulatory requirements and relevant standards related to Quality Systems and support the appropriate requirement or standard owner to ensure effective implementation. Support Training activities. Support Training activities including: maintaining training records, supporting Department Training Coordinator (DTC) program, conducting organization wide training (as needed), assists with on-time training goals, conducts orientation for new personnel (iMERZion), and reviewing DCN training plans.
• Process Improvement Initiatives Drive continuous improvement initiatives / projects for the Quality Systems Department
• Supports Internal, External and Vendor Audit Functions Supports Internal, External and Vendor Audit Functions as needed
• Bachelor's Degree
• 3-5 years Quality experience in Medical Device, Pharmaceutical and/or equivalent regulated industry
• 2+ years Supervisor or Lead Experience

Preferred Qualifications

• ASQ CQA or CMQ/OE

Technical & Functional Skills

• Knowledge of regulatory requirements for medical device / pharmaceutical organization required.
• Strong technical and general problem-solving skills; experience with NCR/CAPA processes
• Medical and/or scientific terminology
• Computer skills in Microsoft Word, Excel, PowerPoint, Visio and Access; Adobe; and Quality System Management Software.
• Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations
• Highly effective communication skills. Ability to work with company staff and communicate effectively throughout the organization.
• Manage multiple priorities and work with interruptions.
• Comprehensive Medical, Dental, and Vision plans
• 20 days of Paid Time Off
• 15 paid holidays
• 401(k)
• And more!

Your benefits and PTO start the date you're hired with no waiting period!

This position is not eligible for employer-sponsored work authorization. Applicants must be legally authorized to work in the United States without the need for current or future employer-sponsored work authorization.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.