Contract Manufacturing Quality Manager

About the business: 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:

Contract Manufacturer Management:

Manage daily interface with contract manufacturer(s) that manufacture for and supply finished medical devices and pharmaceutical product to Merz.

Coordinate changes amongst multiple vendors.

Monitor for ongoing compliance to established agreements, regulations and expectations. Activities include regular review of manufacturing processes (i.e. batch record review, deviation approval, on-site audits etc.

Work with supply chain to ensure continuity of Supply from CMO.

Monitor output and quality of output of CMOs Process transfers and improvements:

Lead product and process transfers to and from CMO.

Evaluate and implement new technologies per Quality System Standards, Quality System Regulations, and other company procedures.

Drive process improvement initiatives at CMO on behalf of legal manufacturer.

Monitor and facilitate reduction in product manufacturing cycle time and increases in capacity at suppliers. Audit Activities:

Perform audits of the CMO sites to ensure compliance to global regulations.

Participate with federal, state, and local regulatory officials during regulatory inspections both at Merz and at Contract Manufacturing facilities. Quality Processes:

Coordinate all approval activities for the legal manufacturer in accordance with global regulations and guidelines.

Facilitate and Manage inter-company change controls and their associated deliverables. Root Cause Analysis and Corrective Actions:

Support Contract Manufacturer's investigations and implementation of meaningful CAPA/SCARs (corrective and preventive actions).

Serve as NCR/SCAR/CAPA approver as necessary to support CMO production releases. Design Transfer Support:

Support organization in the design transfer and implementation of new designs into manufacturing within design control and quality requirements Education:

BS/BA in Engineering or related field Required

Masters degree. Preferred Experience:

5 years Pharmaceutical/ Medical Device Manufacturing Quality. Required

GMP experience. Required

3 years of experience working with EMS Contract Manufacturing Organization. Preferred

Auditing experience, ASQ certification. Preferred Knowledge, Skills and Abilities:

Familiarity with cGMP regulations and FDA/USP/EP/BP/ICH guidelines. Required

Ability to review testing protocols and reports, operating documents and procedures. Required

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

Expertise in industry standards of manufacturing and manufacturing quality controls. Required

Ability to make data driven decisions around manufacturing quality metrics. Preferred

Quality experience including quality testing, QA/Regulatory, or Validation. Experience with FDA, European agency regulations, cGMP regulations and Quality Management software. Preferred

ASQ Certification as a Quality Auditor, Quality Technician, Quality Engineer, or equivalent. Preferred

Ability to work with company staff and communicate effectively throughout the organization is essential. Preferred

Excellent written and oral communication skills. Preferred 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!

Come join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employees!

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This 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.