Supplier Quality Engineer

Merz North America•Caledonia, WI

53d•Onsite

About The Position

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.

Requirements

Bachelor of Engineering (B.E.) BS in a Physical Science or equivalent experience.

Nice To Haves

Minimum 2-4 years Quality Assurance and/or other regulated industry or similar experience.
ASQ Certification as a Quality Engineer, or equivalent.
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.

Responsibilities

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).
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.
Coordinate/Execute the operation of Internal and Supplier Audit Systems. Provide leadership as required while conducting all such audits.
Provide leadership in directing and promoting Quality Improvement processes.
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.
Assist with continued company certification to the appropriate Quality System Standards and Regulations, and assist with all related inspections as required.
Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of medical device, drugs, cosmetics and dietary supplements.
Provide support within the Quality department and to other Merz Aesthetics departments as directed by Quality Management.