Supplier Quality Engineer

Merz North America, Inc.; Northern (KY); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, Dental, Vision plans

20 days PTO

15 paid holidays

401(k)

Job summary

Merz North America, Inc. is seeking a Supplier Quality professional to oversee day-to-day supplier interfaces and evaluate quality systems. You will manage CAPAs, nonconformances, and drive continuous improvements in collaboration with manufacturing and quality teams.

The role requires 2–4 years in QA in regulated environments, ISO 13485/FDA familiarity, and strong audit capabilities. This is a full-time on-site position based in Kentucky.

Qualifications

• Bachelor of Engineering or BS in a physical science or equivalent experience.
• Experience in Quality Assurance within regulated industries is preferred.
• Awareness of ISO 13485, FDA QSR, GMPs or related regulations.

Responsibilities

• Oversee supplier quality and day-to-day interface with supplier manufacturers.
• Drive CAPA, nonconformances, and data analysis for quality improvement.
• Coordinate internal and supplier audits and provide leadership during audits.
• Lead quality improvement processes and manage staff and resources.

Skills

Organizational skills

Prioritization

Problem solving

Effective communication

Audit facilitation

Regulatory knowledge

Statistical analysis

Global/matrix collaboration

Leadership of direct reports

Interpersonal skills

Education

B.E./BS in Physical Science or Eng

ASQ Certification (Quality Engineer)

Job description

About Us
Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics.

A Brief Overview

Responsible for the daily oversight of suppliers, in accordance with product risk profile. Primary Quality Contact for Merz to critical vendors. Merz is as responsible for its products that are manufactured by suppliers as the product manufactured in Merz facilities. Oversight and accountability includes but is not limited to: supplier audits, supplier re-evaluations, supplier ratings, supplier corrective action management, and the facilitation and implementation of process improvement projects. Fulfill the role of product and process SME and / or facilitate the communication between vendor and applicable SME. Evaluate the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations and recommend where corrections or improvements are necessary. Coordinate and execute finished product / raw material management as appropriate to the Quality Department. Provide direct support to Quality Management/Quality Assurance personnel regarding operation of the department and Quality System. Provide support to other departmental activities as directed.

What You Will Do

• 50% - Supplier Quality: Oversee and manage day to day interface with suppliers that manufacture for and supply products to Merz North America (including: Biologics, Rx, OTC, Medical Devices (510K, PMA), Cosmetics and Nutritional Supplements).
• 15% - Nonconformances/ SCARs: Drive the operation of the Quality System process related to Corrective/Preventive actions and product non-conformance control including; capturing data associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting.
• 10% - Audit: Coordinate/Execute the operation of Internal and Supplier Audit Systems. Provide leadership as required while conducting all such audits.
• 10% - Process Improvement: Provide leadership in directing and promoting Quality Improvement processes.
• 5% - Managerial: Manage staff, resources and procedures to support Merz Supplier Quality function. Coach and mentor employees to optimum performance, and recruit and interview qualified applicants, ensure appropriate new-hire training and orientation, and provide on-going training and development of Quality Team.
• 5% - Inspections: Assist with continued company certification to the appropriate Quality System Standards and Regulations, and assist with all related inspections as required.
• 5% - Compliance: Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of medical device, drugs, cosmetics and dietary supplements.
• Further Tasks: Provide support within the Quality department and to other Merz Aesthetics departments as directed by Quality Management.
• Bachelor of Engineering (B.E.) BS in a Physical Science or equivalent experience.

Preferred Qualifications

• Minimum 2-4 years Quality Assurance and/or other regulated industry or similar experience.

• ASQ Certification as a Quality Engineer, or equivalent.

Technical & Functional Skills

Demonstrated strong organizational skills including ability to prioritize tasks and adhere to agreed timelines.

Strong technical and general problem-solving skills .

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

Ability to host, facilitate and execute audits with internal and external audiences.

Excellent written and oral communication skills with attention to detail.

Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations.

Experience with statistical analysis of data.

Ability to work effectively in a global, matrix environment.

Ability to work independently as well as direct and control the efforts of Direct Reports, as applicable.

Strong interpersonal skills and ability to collaborate effectively with various technical area experts.

Comprehensive Medical, Dental, and Vision plans

20 days of Paid Time Off

15 paid holidays

401(k)

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.