Merz Aesthetics
Overview
About Merz 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. Live your best life with Merz Aesthetics. What You Will Do
Supplier 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. Other duties as assigned: 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. Minimum 6 years combination of Medical Device and/or Pharmaceutical experience. ASQ Certified Quality Engineer. Preferred ISO 13485 Lead Auditor Certification. 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. Medical Device Design Control. 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 plans 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 also valuing our employees. This position is not eligible for employer-sponsored work authorization. Applicants must be legally authorized to work in the United States without the need for current or future employer-sponsored work authorization. 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.
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About Merz 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. Live your best life with Merz Aesthetics. What You Will Do
Supplier 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. Other duties as assigned: 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. Minimum 6 years combination of Medical Device and/or Pharmaceutical experience. ASQ Certified Quality Engineer. Preferred ISO 13485 Lead Auditor Certification. 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. Medical Device Design Control. 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 plans 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 also valuing our employees. This position is not eligible for employer-sponsored work authorization. Applicants must be legally authorized to work in the United States without the need for current or future employer-sponsored work authorization. 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.
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