Supplier Quality Engineer - Merz North America, Inc

About the Company:

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

Position: Supplier Quality Engineer:

The Supplier Quality Engineer is responsible for the daily oversight of suppliers, in accordance with the product risk profile. This role acts as the primary Quality Contact for MA with critical vendors. MA holds the same responsibility for products manufactured by suppliers as for those manufactured in MA facilities. Responsibilities include, but are not limited to: supplier audits, supplier re-evaluations, supplier ratings, supplier corrective action management, and the facilitation and implementation of process improvement projects.

Key duties involve serving as the product and process Subject Matter Expert (SME) and facilitating communication between vendors and applicable SMEs. This role also involves evaluating Manufacturing and Quality activities in relation to compliance with Quality Standards and Regulations, recommending necessary corrections or improvements, coordinating and executing finished product/raw material management, and providing direct support to Quality Management/Quality Assurance personnel.

Key Responsibilities:

• 50% - Supplier Quality: Oversee and manage day-to-day interactions with suppliers that manufacture and supply products to Merz North America, including Biologics, Rx, OTC, Medical Devices (510K, PMA), Cosmetics, and Nutritional Supplements.
• 15% - Nonconformances/SCARs: Operate the Quality System process related to Corrective/Preventive actions and product non-conformance control, including capturing and analyzing data associated with product deviations, non-conformances, CAPAs, scrap, and rework for Quality Improvement.
• 10% - Audit: Coordinate and execute Internal and Supplier Audit Systems, providing leadership during these audits.
• 10% - Process Improvement: Lead and promote Quality Improvement processes.
• 5% - Managerial: Manage staff, resources, and procedures to support Merz Supplier Quality function. Responsibilities include coaching, mentoring, recruiting, ensuring appropriate training, and ongoing development of the Quality Team.
• 5% - Inspections: Assist with maintaining company certification to appropriate Quality System Standards and Regulations, and support related inspections as required.
• 5% - Compliance: Ensure adherence to all Federal, State, and Local Regulations controlling the manufacture of medical devices, drugs, cosmetics, and dietary supplements.
• Further Tasks: Provide support within the Quality department and to other Merz Aesthetics departments as directed by Quality Management.

Education:

• BS in a Physical Science or Engineering, or equivalent experience (Required).

Experience:

• Minimum 2-4 years in Quality Assurance and/or other regulated industry or similar experience (Preferred).
• ASQ Certification as a Quality Engineer, or equivalent (Preferred).

Knowledge, Skills, and Abilities

• Strong organizational skills with the ability to prioritize tasks and adhere to timelines.
• Strong technical and general problem-solving skills.
• Effective communication skills throughout the organization.
• Ability to host, facilitate, and execute audits with internal and external audiences.
• Excellent written and oral communication skills with attention to detail.
• Familiarity with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations.
• Experience with statistical analysis of data.
• Ability to work effectively in a global, matrix environment.
• Ability to work independently and manage Direct Reports as applicable.
• Strong interpersonal skills and the ability to collaborate effectively with various technical experts.

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 also valuing 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