Document Control Lead — Quality Systems & Compliance

Merz North America, Inc; Town of Caledonia (WI); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Comprehensive Medical, Dental, and Vis

20 days Paid Time Off

15 paid holidays

Paid Sick Leave

Paid Parental Leave

401(k)

Employee bonuses

Job summary

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

You will drive compliance with ISO 13485, FDA QSR and other regulations, mentor staff, support training, and collaborate across QA and regulatory functions.

This position is not eligible for employer-sponsored work authorization. Applicants must be legally authorized to work in the United States.

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.
• Must be legally authorized to work in the United States.

Responsibilities

• Manage Document Control department and personnel.
• Document Control: ensure global standards and regulations are met.
• Maintain awareness of regulatory changes and support training activities.
• Drive continuous improvement initiatives for the Quality Systems Department.
• Supports Internal, External and Vendor Audit Functions as needed.

Skills

Document Control

Regulatory knowledge

Quality systems

Communication skills

Problem solving

Education

Bachelor's Degree

Tools

Microsoft Word

Excel

PowerPoint

Visio

Access

Adobe

Quality System Management Software

Job description

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

You will drive compliance with ISO 13485, FDA QSR and other regulations, mentor staff, support training, and collaborate across QA and regulatory functions.

This position is not eligible for employer-sponsored work authorization. Applicants must be legally authorized to work in the United States.