Quality Engineer (Architecture)
About the Company:
Merz is a family-owned medical device and pharmaceutical company with headquarters in Germany. Our Global Technical Operations based in WI manufactures, packages, and ships several innovative products so that people all over the world can look better, feel better and live better.
Key Responsibilities
- System Administrator: Manage system helpdesk across multiple software platforms and resolve user issues.
- Technical Support: Responsible for being the primary contact with Technical Support to resolve technical issues across multiple software platforms.
- Software Validation: Responsible for leading and conducting software validations according to GAMP.
- QMS System Improvements: Responsible for quality system improvements including system configuration, upgrades, and validation documentation and execution.
- SOP Maintenance / Support: Provide input in creation and/or review of internal operating procedures.
- Compliance to Regulatory Requirements: 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.
- Quality Support: Provide support for the Quality Assurance/Operations Departments and to other company departments as directed by Global Quality Systems Management
Education
- Bachelor's Degree in Computer Science and/or Life Sciences (Required)
Professional experience
- 2-3 years of computer software support, software validation and/or related experience (Required)
Knowledge, skills, and abilities
- Proficient in MS Word, Excel, and PowerPoint software programs (Required)
- Excellent verbal and written communication skills and leadership skills (Required)
- Ability to work with company staff and communicate effectively throughout the organization is essential (Required)
- Familiar with industry standards and Federal Regulations (Required)
- GAMP (Required)
- Root Cause Analysis tools (Required)
- Strong technical writing and general problem-solving skills (Required)
- Experience with MES systems (Preferred)
- Experience with statistical analysis of data (Preferred)
Must be able to pass vision testing requirements (with or without corrective eyewear).
- 20/20 Near Acuity Vision
Benefits:
- Comprehensive Medical, Dental, and Vision plans
- 20 days of Paid Time Off
- 15 paid holidays
- 401(k)
- Employee bonuses
- And more!
Your benefits and PTO start the date you are hired with no waiting period! 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 60-1.35(c)
Quality
