Manager, Analytical Quality Lab - Merz North America, Inc

Are you ready to advance your career and lead a team of Quality Technicians in the biomedical field? Are you passionate about development and mentoring? This role will help build on a successful Quality Control team in a rapidly growing medical device company.

About the Company: 

Merz is a family-owned medical device and pharmaceutical company headquartered in Germany. Our Global Technical Operations based in WI manufactures, packages and ships several innovative products so that people all over the world can live better, feel better, and look better.

Key Responsibilities: 

• 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
• Evaluate and implement new analytical technologies per Quality System Standards, Quality System Regulations, and other company procedures around which the Quality System is developed
• Serve as a resource for manufacturing to determine best course of action and material dispositions for investigations and unexpected occurrences.
• Ensure completion of all testing, including raw materials, in-process, final release, stability, environmental, biological and special project/protocol testing in a timely manner that achieves fulfillment to commitments ey tasks
• Participate in external audits as a subject matter expert on test method, test method validation, and test method development

Education

• BS in Physical Science or related field Required
• Advanced degree (MS, PhD, etc.) in a physical science field Preferred

Experience

• GLP/GMP experience Required
• At least 5 years’ experience Pharmaceutical or Medical Device Laboratory Required
• Supervision/leadership experience Preferred
• Familiarity with cGMP regulations and FDA/USP/EP/BP/ICH guidelines Required
• Quality experience may include quality testing (analytical chemistry/microbiology), QA/Regulatory, or Validation. Required
• Experience with FDA, European agency regulations, cGMP regulations, Laboratory Information Required
• Knowledge of quality systems, quality techniques, current regulatory requirements and technical issues resolution. Required

Must be able to pass vision testing requirements (with or without corrective eyewear).

   - 20/20 Near Acuity Vision

Schedule:  Monday-Friday 7:00am-3:30pm

Benefits: 

• Comprehensive Medical, Dental, and Vision plans
• 20 days of Paid Time Off
• 15 paid holidays
• Paid Sick Leave
• 401(k)
• And more!

Your benefits and PTO start the date you're 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