- Partnering with internal and external partners in the design, engineering, validation and implementation of data, software, or technology solutions by studying information needs; conferring with users; studying systems flow, data usage, and work processes; investigating problem areas; Routinely demonstrate initiative and creativity in developing technology solutions.
- Serving as technical expert or lead projects/programs and technical staff to develop, test and implement significant new products, or operational improvements or devise new approaches to problems at the division/business unit.
- Analyzing and resolving technical problems using analytical problem-solving methods/techniques and associated tools/devices.
- Contributing to the advancement of functional capabilities by studying state-of-the-art tools, techniques, and computing equipment; participate in educational opportunities and professional organizations.
- Demonstrating high proficiency across a wide range of technologies and platforms related to software design and development, programming languages, data integration, data warehousing, data analysis and visualization tools, data storage, network connectivity, and virtualization/cloud environments.
- Operating in a highly autonomous environment, in performing activities requiring only minimal direction from or interaction with supervisor.
- Total project scope, budget, completion within budget constraints and scheduled completion date. Accountable for successful and timely completion of all tasks/projects under direct and matrix control.
- Initiating new areas of investigation that are meaningful, reliable, and can be incorporated directly into a scientific or business activity.
- Providing technical leadership and mentors and consults with less experienced staff in planning, methods, procedures, standards, and best practices.
- 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.
- Understanding and adhering to Merz standards regarding applicable Policies, including code of conduct, safety, GxP compliance, data security, and the software development lifecycle.
- Must be proficient in MS Word, Excel, and PowerPoint software programs.
- Must have excellent verbal and written communication skills and leadership skills.
- Possess thorough theoretical and practical understanding of regulated software systems (i.e. manufacturing execution systems and processes, eQMS, SAP, LIMs etc.).
- Proven implementation of creative technology solutions that advanced the business.
- Ability to work with company staff and communicate effectively throughout the organization is essential.
- Familiar with industry standards and Federal Regulation.
- GAMP. - Required
- Windows server administration. - Preferred
- Infrastructure design and security hardening experience. - Preferred
- Network administration experience (to support troubleshooting).
- MES Administration/Troubleshooting. - Preferred
- End user experience.
- SEC. - Preferred
- Statistical analysis of data. - Preferred
- Root Cause Analysis Tools.
- Strong technical writing and general problem-solving skills.
- Bachelor's Degree. - Required
- Concentration in in Computer Science and/or Life Sciences. - Preferred
- 6 years of GxP computer software support and/or related experience. - Required
- 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
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Sr. Quality Engineer, Business Technology - Racine, United States - Merz North America
Description
About the Company:Family owned since 1908 Merz Aesthetics is the world's largest dedicated medical aesthetics business. Choose Merz Aesthetics because it is unique - unique in our relationships with customers, in our products and in the way we treat each other.
As Sr. Quality Engineer, Business Technology, you will provide end-to-end technical guidance and business process alignment through delivering and maintaining Business Technology solutions and systems for Technical Operations (Manufacturing Execution System (MES), Enterprise Resource Planning (ERP), Electronic QMS (eQMS), Laboratory Information Management Systems (LIMs) etc.). In partnership with a cross functional team, you will support the creation and maintenance of the site technology roadmap, advocating for and enabling a unified approach to digitalization and executing projects that deliver innovation and digital enablement of the manufacturing, supply chain and quality business imperatives.
Key Responsibilities:
Come join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employees
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR c)
