Document Control Manager, Quality Systems Lead

Merz North America, Inc.; Northern (KY); Hybrid; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical insurance

Dental & Vision insurance

Paid time off

401(k)

Job summary

Merz North America, Inc. is seeking an Associate Manager, Document Control to lead the Document Control team and drive the validation, approval and release of Merz QMS documents.

You will coordinate and review activities to ensure adherence to global standards, regulations, and the Merz Quality System. The role requires 3–5 years in quality within medical devices/pharma, plus 2+ years in a supervisory capacity.

Qualifications

• Bachelor's Degree required.
• 3-5 years Quality experience in Medical Device, Pharmaceutical and/or equivalent regulated industry.
• 2+ years Supervisor or Lead Experience.
• Knowledge of regulatory requirements for medical device / pharmaceutical organization.
• Strong technical and general problem-solving skills; NCR/CAPA experience.
• Computer skills in Microsoft Word, Excel, PowerPoint, Visio and Access; Adobe; and Quality System Management Software.

Responsibilities

• Manage the Document Control department and personnel to meet goals, deadlines and performance standards.
• Oversee all aspects of the Document Control function to meet global standards and regulations.
• Maintain awareness of changes to global regulatory requirements and assist in implementing relevant standards; support training activities.
• Drive continuous improvement initiatives and projects for the Quality Systems Department.
• Support internal, external and vendor audit functions as needed.

Skills

Leadership

Communication

Problem-solving

Multi-tasking

Education

Bachelor's Degree

ASQ CQA or CMQ/OE

Tools

Word

Excel

PowerPoint

Visio

Access

Adobe

Job description

Merz North America, Inc. is seeking an Associate Manager, Document Control to lead the Document Control team and drive the validation, approval and release of Merz QMS documents.

You will coordinate and review activities to ensure adherence to global standards, regulations, and the Merz Quality System. The role requires 3–5 years in quality within medical devices/pharma, plus 2+ years in a supervisory capacity.