Supplier Quality Engineer (Architecture)
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
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Demonstrated strong organizational skills including ability to prioritize tasks and adhere to agreed timelines.
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Strong technical and general problem-solving skills .
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Ability to work with company staff and communicate effectively throughout the organization.
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Ability to host, facilitate and execute audits with internal and external audiences.
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Excellent written and oral communication skills with attention to detail.
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Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations.
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Experience with statistical analysis of data.
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Ability to work effectively in a global, matrix environment.
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Ability to work independently as well as direct and control the efforts of Direct Reports, as applicable.
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Strong interpersonal skills and ability to collaborate effectively with various technical area experts.
Benefits
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Comprehensive Medical, Dental, and Vision plans
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20 days of Paid Time Off
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15 paid holidays
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Paid Sick Leave
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Paid Parental Leave
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401(k)
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Employee bonuses
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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. Supplier Quality Assurance
