Supplier Quality Engineer

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.

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 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.

Responsibilities

• 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, non‑conformances, CAPAs, scrap and rework, analyzing the data for quality improvement reasons, and reporting.
• 10% – Audit: Coordinate/execute the operation of Internal and Supplier Audit Systems and provide leadership 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, recruit and interview qualified applicants, ensure new‑hire training and orientation, and provide ongoing training and development of the Quality Team.
• 5% – Inspections: Assist with continued company certification to the appropriate Quality System Standards and Regulations, and support all related inspections as required.
• 5% – Compliance: Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of medical devices, drugs, cosmetics and dietary supplements.
• Provide support within the Quality department and to other Merz Aesthetics departments as directed by Quality Management.

Minimum Requirements

• 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

• Strong organizational skills with ability to prioritize tasks and meet agreed timelines
• Technical and general problem‑solving abilities
• Effective communication across the organization
• Ability to host, facilitate and execute audits with internal and external audiences
• Excellent written and oral communication skills with attention to detail
• Familiarity with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and other international medical device regulations
• Experience with statistical analysis of data
• Ability to work effectively in a global, matrix environment
• Capability to work independently as well as direct and control the efforts of direct reports
• Strong interpersonal skills and ability to collaborate with various technical experts

Benefits

• Comprehensive Medical, Dental, and Vision plans
• 20 days of Paid Time Off
• 15 paid holidays
• Paid Sick Leave
• Paid Parental Leave
• 401(k) plan
• Employee bonuses
• Additional benefits and PTO start on the date of hire with no waiting period