About this opportunity
Merz North America, Inc lists this Quality Investigations Engineer opportunity in town of caledonia, Wisconsin. Review the employer’s description below for duties, qualifications and application requirements.
Job description
About Us
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. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics.
A Brief Overview
This position is responsible for providing Quality Engineering and Technical Support for operations, sustaining engineering, R&D, and New Product Introduction. This position would include supporting NCR and CAPA activities. This position would evaluate the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations and recommend where corrections or improvements are needed. Provide direct support to Quality personnel regarding operation of the department and Quality System. Provide support to other departmental activities as directed.
What You Will Do
Quality Initiatives: Identify new quality improvement initiatives / projects in accordance with cGMP expectations to improve compliance, quality levels (reducing defects), and improve operational efficiencies. Works with manufacturing and other functional groups on manufacturing regulatory compliance issue. Support training program by delivering assigned training tasks
NCR and CAPA: Support / lead corrective/preventive actions and product non-conformance including capturing data and investigations associated with product deviations, product non-conformances (NCR), CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting. Conduct CAPA and NCR review and approvals. Run the Material Review Board (MRB)
Adherence to Regulations Assist with adherence to all Federal, State and Local Regulations controlling the manufacture medical devices, cosmetics, and pharmaceuticals.
Inspections: Support with federal, state, and local regulatory officials during regulatory inspections Other duties as assigned. Provides support to Quality Management personnel and perform other duties as assigned Remote Work Eligibility. Allowed up to 2 days per week in accordance with policy
Management: For those who manage or supervise staff: Manage staff including interviewing, hiring, training, and developing employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems
Minimum Requirements
Bachelor of Science (B.S.) in Engineering or equivalent experience
2+ years in Medical Device or similar experience
Preferred Qualifications
2 years in a quality role
ASQ Certification as a Quality Engineer or equivalent Upon Hire
Technical & Functional Skills
Knowledge of regulatory requirements for medical device / pharmaceutical organization
Strong technical and general problem-solving skills required; experience with NCR/CAPA processes
Computer skills in Microsoft Word, Excel, PowerPoint, Visio and Access; Adobe; and Quality System Management Software
Familiar with ISO 13485 Quality System Standards, ISO 14971, FDA Quality System Regulations, GMPs, and/or other international medical device regulations
Highly effective communication skills. Ability to work with company staff and communicate effectively throughout the organization.
Manage multiple priorities and work with interruptions.
Ability to work with minimal supervision and to make effective decisions for issues of a diverse and complex scope when required.
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!
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.
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.