Document Control Manager, Quality Systems

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

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.