Supplier Quality Engineer: Audits & CAPAs

Merz North America, Inc; Town of Caledonia (WI); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical, Dental, Vision plans

20 days of Paid Time Off

15 paid holidays

Paid Sick Leave

Paid Parental Leave

401(k)

Employee bonuses

And more!

Job summary

Merz North America, Inc is seeking a Quality Assurance professional to oversee supplier quality and ensure compliance with regulatory standards. The role acts as the primary quality contact for critical vendors and supports quality assurance activities across biologics, Rx, OTC, medical devices, cosmetics and nutritional products.

You will lead supplier audits, CAPA management, nonconformance control, and process improvements while coaching the quality team.

Qualifications

• Bachelor of Engineering or BS in Physical Science required.
• 2–4 years QA or regulatory experience preferred.
• ASQ Certification or equivalent.
• Strong organizational and problem-solving abilities.
• Excellent written and verbal communication.
• Familiar with ISO 13485, FDA QSR, GMP and related regs.
• Experience with data statistical analysis.
• Ability to work in a global matrix environment.

Responsibilities

• Oversee supplier quality for Merz North America across products.
• Lead CAPA and nonconformance management.
• Coordinate internal and supplier audits.
• Drive quality process improvements.
• Manage Quality staff and training.
• Assist with inspections and regulatory compliance.
• Support Quality department and other Merz Aesthetics departments.

Skills

Organizational skills

Problem-solving

Communication

Auditing

Documentation

ISO 13485

Statistical analysis

Matrix environment

Independence

Interpersonal skills

Education

B.E./B.S. in Physical Science

ASQ Certification

Job description

Merz North America, Inc is seeking a Quality Assurance professional to oversee supplier quality and ensure compliance with regulatory standards. The role acts as the primary quality contact for critical vendors and supports quality assurance activities across biologics, Rx, OTC, medical devices, cosmetics and nutritional products.

You will lead supplier audits, CAPA management, nonconformance control, and process improvements while coaching the quality team.