Quality Investigations Engineer

Merz•Racine, WI

7d•Hybrid

About The Position

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.

Requirements

Bachelor of Science (B.S.) in Engineering or equivalent experience
2+ years in Medical Device or similar experience
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
Highly effective communication skills. Ability to work with company staff and communicate effectively throughout the organization.
Manage multiple priorities and work with interruptions.
Ability to work with minimal supervision and to make effective decisions for issues of a diverse and complex scope when required.

Nice To Haves

2 years in a quality role
ASQ Certification as a Quality Engineer or equivalent Upon Hire

Responsibilities

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.
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).
Assist with adherence to all Federal, State and Local Regulations controlling the manufacture medical devices, cosmetics, and pharmaceuticals.
Support with federal, state, and local regulatory officials during regulatory inspections.
Provides support to Quality Management personnel and perform other duties as assigned.
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.