Merz Aesthetics
Supplier Quality Engineer/ Sr. Supplier Quality Engineer
Merz Aesthetics, Racine, Wisconsin, United States, 53404
Supplier Quality Engineer/ Sr. Supplier Quality EngineerLocation:
Racine, WI, USA
Category:
Clinical/Medical/Regulatory Affairs
Job Id:
SUPPL003777
Job Type:
Full Time
Posted Date:
08/21/2024
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. Oversight and accountability include but is not limited to supplier audits, supplier re-evaluations, supplier score carding, supplier corrective action management, and the facilitation and implementation of process improvement projects.
Key Responsibilities:
Sr. Supplier Quality EngineerSupplier Quality
Oversee and manage day to day interface with suppliers that manufacture for and supply products to Merz North America predominantly Medical Device (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 the reasons of 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 device, 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.
Supplier Quality EngineerSupplier 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).
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.
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.
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.
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 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.
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 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.
Sr. Supplier Quality Engineer
Medical Device Design Control
Benefits:
Comprehensive Medical, Dental, and Vision plan.
20 days of Paid Time Off
15 paid holidays
Paid Sick Leave
Paid Parental Leave
401(k)
Employee bonuses
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!
#J-18808-Ljbffr
Racine, WI, USA
Category:
Clinical/Medical/Regulatory Affairs
Job Id:
SUPPL003777
Job Type:
Full Time
Posted Date:
08/21/2024
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. Oversight and accountability include but is not limited to supplier audits, supplier re-evaluations, supplier score carding, supplier corrective action management, and the facilitation and implementation of process improvement projects.
Key Responsibilities:
Sr. Supplier Quality EngineerSupplier Quality
Oversee and manage day to day interface with suppliers that manufacture for and supply products to Merz North America predominantly Medical Device (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 the reasons of 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 device, 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.
Supplier Quality EngineerSupplier 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).
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.
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.
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.
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 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.
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 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.
Sr. Supplier Quality Engineer
Medical Device Design Control
Benefits:
Comprehensive Medical, Dental, and Vision plan.
20 days of Paid Time Off
15 paid holidays
Paid Sick Leave
Paid Parental Leave
401(k)
Employee bonuses
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!
#J-18808-Ljbffr