Associate Manager, Document Control

Merz Aesthetics; Franksville (WI); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical, Dental, Vision

20 days PTO

15 paid holidays

Paid Sick Leave

Paid Parental Leave

401(k)

Employee bonuses

Job summary

Merz Aesthetics in Wisconsin is seeking an Associate Manager, Document Control to lead the Document Control team and oversee the creation, revision, approval and release of QMS documents.

You will ensure compliance with ISO 13485, FDA QSR and related regulations, support training programs and internal/external audits, and drive continuous process improvements across the Quality System.

Qualifications

• Bachelor's degree in a related field; 3–5 years quality experience in medical device/pharmaceutical
• 2+ years supervisor or lead experience
• ASQ CQA or CMQ/OE certification preferred

Responsibilities

• Lead Document Control department and personnel.
• Ensure all aspects of Document Control meet global standards and regulations.
• Maintain awareness of regulatory changes and support implementation.
• Drive continuous improvement initiatives for the Quality Systems Department.
• Support internal, external and vendor audits as needed

Skills

Document Control

Leadership

Regulatory compliance

Quality Systems

Training coordination

Regulatory knowledge

Communication skills

Problem solving

Education

Bachelor's Degree

ASQ CQA or CMQ/OE (preferred)

Tools

NCR/CAPA systems

Quality System Management Software

Job description

About Us

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.

About Us

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

Minimum Requirements

• 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
• Professional phone etiquette plus careful handling of sensitive information
• 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
• Organized, attention to detail
• Highly effective communication skills. Ability to work with company staff and communicate effectively throughout the organization.
• Manage multiple priorities and work with interruptions.

Benefits

• Comprehensive Medical, Dental, and Vision plans
• 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!

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.