Applications Quality Engineer

Merz North America • Racine, WI

99d

About The Position

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. This role is responsible for supporting the development, implementation, and maintenance of Quality System applications and data visualization tools. It supports the development, implementation, and optimization of digital solutions that enhance operational excellence across quality and manufacturing processes. This role will provide support of applicable business applications and data visualization tools.

Requirements

• Bachelor's Degree in Computer Science and/or Life Sciences.
• 2+ years Medical Device or Pharmaceutical Manufacturing and/or other regulated industry or similar experience.
• Proficient in MS Word, Excel, and PowerPoint software programs.
• Excellent verbal and written communication skills and leadership skills.
• Ability to work with company staff and communicate effectively throughout the organization.
• Familiar with industry standards and Federal Regulations.
• Strong understanding of industry standards and best practices for computer validation such as GAMP 5, 21 CFR Part 11, Annex 11, etc.
• Experience in application configuration.
• Strong technical writing and general problem-solving skills.

Responsibilities

• Provide application support by managing user accounts, permissions, and security policies.
• Provide technical assistance to users as required.
• Troubleshoot issues and conduct training on new features and system use.
• Support the handling of incidents until they are fully resolved, with a detailed analysis of the underlying causes provided.
• Configure applications which align with business requirements in collaboration with internal or external design engineers.
• Support the principal designer for major systems and their subsystems.
• Collaborate with key stakeholders to support system upgrades and enhancements.
• Follow robust and validated processes for making changes.
• Support or execute planning, development, and implementation of computer systems validation documentation and ensure compliance with required GxP and 21 CFR Part 11 regulations.
• Provide input in creation and/or review of internal operating procedures.
• Assist in ensuring applicability of current quality policies, procedures and objectives by keeping informed of the latest updates/modifications related to industry standards and federal regulations.
• Build relationships with end users and provide a positive working experience.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Wholesale Trade Agents and Brokers
• Education Level: Bachelor's degree