Quality Engineering S
Merz Pharma
About UsFounded 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.A Brief OverviewResponsible 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. 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. What You Will Do50% - Supplier Quality: 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.10% - Audit: Coordinate/Execute the operation of Internal and Supplier Audit Systems. 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 RequirementsBachelor of Engineering (B.Preferred QualificationsMinimum 2-4 years Quality Assurance and/or other regulated industry or similar experience.ASQ Certification as a Quality Engineer, or equivalent.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.BenefitsComprehensive Medical, Dental, and Vision plans20 days of Paid Time Off15 paid holidaysPaid Sick LeavePaid Parental Leave401(k)Employee bonusesAnd more!Come join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employees!Supplier Quality AssuranceSchedule: Full-Time
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