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.
Key Responsibilities :
- Identify program improvement for site compliance activities.
- Lead company certification efforts to the appropriate Quality System Standards and Regulations and coordinate related inspections and follow up activities as required.
- Oversee Internal / External Audit program. Provide leadership and subject matter expertise as required while conducting audits.
- Oversee the integration of Global Quality Policies into Merz North America, Inc. Quality Management System.
- Ensure adherence to Federal, State and Local Regulations controlling the manufacture and distribution of medical devices and accessories, pharmaceuticals, cosmetics and Over the Counter (OTC).
- Assist with GMP training to all company employees as required.
- Generate, review and approve internal operating procedures and specifications.
- Provide support within the Quality department and to other Merz departments as directed by Quality Management.
Education :
- Bachelor's Degree in Science, Medical, or Engineering. Required
- ASQ Certified Quality Auditor or equivalent. Preferred
Experience :
- 5 years Medical Device, Pharmaceutical / biotechnology industry experience including at least 2 years in Quality. Required
- 2 years Auditor Internal, External and / or Supplier experience. Required
Knowledge, Skills and Abilities :
- Excellent written and oral communication skills with attention to detail.
- Demonstrated strong organizational skills including ability to prioritize tasks and adhere to agreed timelines.
- Ability to host, facilitate and execute audits with internal and external audiences.
- Knowledge and understanding of US and ex-US regulations and ICH guidelines.
- Highly computer literate (Word, Excel, PowerPoint), including formatting and getting documents submission-ready.
- Thorough understanding and knowledge of documentation, records management, and change control for Quality System requirements in support of GxP regulations.
- Ability to work effectively in a global environment.
- Ability to work independently as well as direct, and control the efforts of Direct Reports as applicable.
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!
Come join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employees!
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