About the Company:

Merz is a family-owned medical device and pharmaceutical company headquartered in Germany. Our Global Technical Operations based in WI manufactures, packages and ships several innovative products so that people all over the world can live better, feel better, and look better.

Key Responsibilities:

Quality Initiatives

• Interpret Quality Standard/ Regulation to perform gap assessment and corrective actions for compliance to Standards / Regulations.

• Coordinates process improvement initiatives for the Quality Department.

• Generate, review and approve internal operating procedures and specifications.

Adherence to Regulations

• Assist with adherence to all Federal, State and Local Regulations controlling the manufacture and distribution of medical devices and accessories, pharmaceuticals, cosmetics and Over the Counter (OTC).

• Assist with continued company certification to the appropriate Quality System Standards and Regulations and assist with all related inspections as required.

Inspections

• Support with federal, state, and local regulatory officials during regulatory inspections.

• Support in internal and vendor quality system audits as applicable.

• Support coordination of compliance activities, including audit schedules, communication, tracking and follow-up.

Other Duties as Assigned

• Provides support to Quality Management personnel and perform other duties as assigned.

Education:

• Bachelor's Degree, or equivalent experience - Required
• BS/BA in Engineering or Physical Science - Preferred

Experience:

• 2 years Quality and/or Regulatory experience in regulated industry, or similar experience - Preferred

• ASQ Certification as a Quality Auditor, Quality Engineer, or equivalent - Preferred

• GLP/GMP experience - Preferred

Knowledge, Skills and Abilities:

• Understanding of documentation, records management, and change control for Quality System requirements in support of GxP regulations.

• Computer skills including those associated with the word processing, spread sheet programs, databases and statistical analysis.

• Ability to work effectively in a global environment and with various departments.

• Ability to work with little or no supervision and make effective decisions.