Merz North America, Inc.
Supplier Quality Engineer/ Sr. Supplier Quality Engineer
Merz North America, Inc., Racine, Wisconsin, United States, 53404
Supplier Quality Engineer/ Sr. Supplier Quality Engineer
About the Company: Merz is a family-owned medical device and pharmaceutical company headquartered in Germany. Our Global Technical Operations based in WI manufactures, packages and ships several innovative products so that people all over the world can live better, feel better, and look better.Responsible for the daily oversight of vendors, in accordance with product risk profile. Primary Quality Contact for Merz to critical vendors. Merz is responsible for its products that are manufactured by vendors as well as the products manufactured in Merz facilities. Oversight and accountability include but are not limited to supplier audits, supplier re-evaluations, supplier score carding, 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 with 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 the operation of the department and Quality System.Key Responsibilities:Sr. Supplier Quality Engineer
Oversee and manage day-to-day interface with suppliers that manufacture for and supply products to Merz North America, predominantly Medical Devices (510K, PMA), but also including Biologics, Rx, OTC, Cosmetics, and Nutritional Supplements.Ensure products are consistently manufactured in accordance with Tech Files, Dossiers, Specifications, etc.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 Quality Improvement and reporting.Audit
Coordinate/Execute the operation of Internal and Supplier Audit Systems. Provide leadership as required while conducting all such audits.Process Improvement
Provide leadership in directing and promoting Quality Improvement processes.Inspections
Assist with continued company certification to the appropriate Quality System Standards and Regulations and assist with all related inspections as required.Compliance
Assist with adherence to all Federal, State, and Local Regulations controlling the manufacture of medical devices, drugs, cosmetics, and dietary supplements.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.Other duties as assigned.Provide support within the Quality department and to other Merz Aesthetics departments as directed by Quality Management.Education:
BS in a Physical Science or Engineering, or equivalent experience.Professional Experience:
Sr. Supplier Quality Engineer
Minimum 6 years combination of Medical Device and/or pharmaceutical experience.ASQ Certification as a Quality Engineer, Lead Auditor or equivalent.Supplier Quality Engineer
Minimum 2-4 years Quality Assurance and/or other regulated industry or similar experience.ASQ Certification as a Quality Engineer, or equivalent.Knowledge, Skills, and Abilities:
Demonstrated strong organizational skills including the 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:
Comprehensive Medical, Dental, and Vision plan.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!
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About the Company: Merz is a family-owned medical device and pharmaceutical company headquartered in Germany. Our Global Technical Operations based in WI manufactures, packages and ships several innovative products so that people all over the world can live better, feel better, and look better.Responsible for the daily oversight of vendors, in accordance with product risk profile. Primary Quality Contact for Merz to critical vendors. Merz is responsible for its products that are manufactured by vendors as well as the products manufactured in Merz facilities. Oversight and accountability include but are not limited to supplier audits, supplier re-evaluations, supplier score carding, 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 with 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 the operation of the department and Quality System.Key Responsibilities:Sr. Supplier Quality Engineer
Oversee and manage day-to-day interface with suppliers that manufacture for and supply products to Merz North America, predominantly Medical Devices (510K, PMA), but also including Biologics, Rx, OTC, Cosmetics, and Nutritional Supplements.Ensure products are consistently manufactured in accordance with Tech Files, Dossiers, Specifications, etc.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 Quality Improvement and reporting.Audit
Coordinate/Execute the operation of Internal and Supplier Audit Systems. Provide leadership as required while conducting all such audits.Process Improvement
Provide leadership in directing and promoting Quality Improvement processes.Inspections
Assist with continued company certification to the appropriate Quality System Standards and Regulations and assist with all related inspections as required.Compliance
Assist with adherence to all Federal, State, and Local Regulations controlling the manufacture of medical devices, drugs, cosmetics, and dietary supplements.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.Other duties as assigned.Provide support within the Quality department and to other Merz Aesthetics departments as directed by Quality Management.Education:
BS in a Physical Science or Engineering, or equivalent experience.Professional Experience:
Sr. Supplier Quality Engineer
Minimum 6 years combination of Medical Device and/or pharmaceutical experience.ASQ Certification as a Quality Engineer, Lead Auditor or equivalent.Supplier Quality Engineer
Minimum 2-4 years Quality Assurance and/or other regulated industry or similar experience.ASQ Certification as a Quality Engineer, or equivalent.Knowledge, Skills, and Abilities:
Demonstrated strong organizational skills including the 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:
Comprehensive Medical, Dental, and Vision plan.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!
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