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.
Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThis 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.
Skills Required
- Bachelor's degree
- 3-5 years of quality experience in the medical device, pharmaceutical, or equivalent regulated industry
- 2+ years of supervisor or lead experience
- ASQ CQA or CMQ/OE certification
- Knowledge of regulatory requirements for medical device or pharmaceutical organizations
- Experience with NCR/CAPA processes
- Knowledge of ISO 13485, FDA Quality System Regulations, GMPs, or international medical device regulations
- Proficiency with Microsoft Word, Excel, PowerPoint, Visio, Access, Adobe, and Quality System Management Software
- Strong communication, organization, problem-solving, and attention-to-detail skills
What We Do
Merz Aesthetics is a medical aesthetics business with a long history of empowering health care professionals, patients and employees to live every day with confidence. We aim to help people around the world look, feel and live like the best versions of themselves — however they define it. Clinically proven, its product portfolio includes injectables, devices and skin care treatments designed to meet each patient’s needs with high standards of safety and efficacy. Being family owned for more than 115 years, Merz Aesthetics is known for building unique connections with customers who feel like family. Merz Aesthetics’ global headquarters is in Raleigh, N.C., USA, with a commercial presence in 90 countries worldwide. It is also a part of Merz Group, which was founded in 1908 and is based in Frankfurt, Germany. Learn more at merzaesthetics.com.
