Supplier Quality Engineer

Merz North America

Racine (WI)

On-site

USD 85,000 - 115,000

Full time

9 days ago

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Benefits offered by this job

Comprehensive Medical, Dental, and Vis

20 days of Paid Time Off

15 paid holidays

Paid Sick Leave

Paid Parental Leave

401(k)

Employee bonuses

Job summary

Merz North America is seeking a qualified QA professional to oversee supplier quality and ensure compliance across regulated products. This role focuses on supplier audits, CAPA, non-conformances, and quality system improvements to support Merz Aesthetics’ portfolio.

Responsibilities include leading internal and supplier audits, managing CAPAs, coaching staff, and collaborating with cross-functional teams to maintain regulatory readiness and product quality across biologics, Rx, OTC, medical

Qualifications

Bachelor of Engineering (B.E.) or BS in a Physical Science or equivalent experience.
Minimum 2-4 years Quality Assurance and/or other regulated industry experience.
ASQ Certification as a Quality Engineer, or equivalent.

Responsibilities

Oversee day-to-day interface with suppliers that manufacture for Merz North America.
Drive Corrective/Preventive actions and CAPAs within the Quality System.
Coordinate Internal and Supplier Audits and provide leadership during audits.
Lead Quality Improvement initiatives and mentor staff in the QA team.
Support compliance with Federal, State, and Local regulations.

Skills

Organizational skills

Problem-solving

Communication

Audits

Documentation

Education

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

Tools

Statistical analysis

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.

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

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.

Benefits