Quality Investigations Engineer

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.

This position is responsible for providing Quality Engineering and Technical Support for operations, sustaining engineering, R&D, and New Product Introduction.

This position would include supporting NCR and CAPA activities.

This position would evaluate the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations and recommend where corrections or improvements are needed.

Provide direct support to Quality personnel regarding operation of the department and Quality System.

Provide support to other departmental activities as directed.

Key Responsibilities:

Quality initiatives
• Identify new quality improvement initiatives / projects in accordance with cGMP expectations to improve compliance, quality levels (reducing defects), and improve operational efficiencies.
• Works with manufacturing and other functional groups on manufacturing regulatory compliance issue.
• Support training program by delivering assigned training tasks.

NCR and CAPA
• Support / lead corrective/preventive actions and product non-conformance including capturing data and investigations associated with product deviations, product non-conformances (NCR), CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting.
• Conduct CAPA and NCR review and approvals.
• Run the Material Review Board (MRB).

Adherence to regulations
• Assist with adherence to all Federal, State and Local Regulations controlling the manufacture medical devices, cosmetics, and pharmaceuticals.

Inspections
• Support with federal, state, and local regulatory officials during regulatory inspections.

Other duties as assigned
• Provides support to Quality Management personnel and perform other duties as assigned.

Education:

• BS in Engineering or equivalent experience.

Required

Experience:

• 2 years in Medical Device or similar experience.

Required
• 2 years in a quality role.

Preferred
• ASQ Certification as a Quality Engineer or equivalent.

Preferred

Knowledge Skills and Abilities:

• Knowledge of regulatory requirements for medical device / pharmaceutical organization.
• Strong technical and general problem-solving skills required; experience with NCR/CAPA processes.
• Computer skills in Microsoft Word, Excel, PowerPoint, Visio and Access; Adobe; and Quality System Management Software.
• Familiar with ISO 13485 Quality System Standards, ISO 14971, FDA Quality System Regulations, GMPs, and/or other international medical device regulations

Benefits:
• Comprehensive Medical, Dental, and Vision plans
• 20 days of Paid Time Off
• 15 paid holidays
• Paid Sick Leave
• Paid Pa...