Quality Engineer, Sr. MFG

Depth of experience

Core Responsibilities will be focused on small to medium sized QMS and Operational SOP remediation projects, including various subsystems of the Quality Management System and Production/Environment.

Will be responsible to solve problems and implement solutions in the active quality/production environment – this includes troubleshooting with affected cross functional teams, execution through the change control process (EDMS - MasterControl), and successful implementation of the updated documentation in the quality/production environment where there is Work in Process (WIP).

Development of solutions and execution of the proposed changes are both critical elements of this position.

Execution of CAPA investigations and implementation of CAPA action plans, along with tracking and completing verifications to demonstrate CAPA effectiveness will be required as well.

A self-starter, active, and hands-on person is needed for this role that will need to complete tasks and deliverables with minimal oversight. Strong engineering background is required, along with depth of experience with Medical Device manufacturing and compliance to regulatory standards (Class III Medical Device experience preferred).

Qualifications, Knowledge, and Skills Required

• Engineering BS Degree with minimum of 2-4 years relevant working experience in Medical Device Industry.
• Extensive knowledge of engineering and scientific principles, concepts, and application.
• Demonstrated strong initiative and follow through in executing responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or leadership experience.
• Demonstrated and continuous track record of contributing to and completing technical assignments with command and leadership, specifically for quality and manufacturing issue resolution, remediation, and change implementation.
• Strong background and extensive experience with completing content/documentation and implementing changes for CAPAs
• Experience with chemical/analytical testing and manufacturing/controlled environment monitoring testing
• Excellent organizational skills
• Excellent verbal and written communication skills.
• Experience with MasterControl (EDMS) and JDE (ERP) strongly preferred

Essential Duties and Position Responsibilities

Examples of Areas/Processes requiring remediation activity:

• Nonconforming material – Scrap process and interface with ERP system (JDE)
• Out of Specification process (Chemistry and Microbiology testing)
• Controlled Environment specifications and documentation/approvals for excursions
• Equipment cleaning
• Equipment repairs (unscheduled)
• Line clearance
• Controlled temperature storage
• GDP
• Production Controls
• Laboratory Controls
• Shipping and Receiving
• Warehouse and FG storage
• Environmental Monitoring
• Purified Water System
• Lot Release
• Approved Supplier List
• Manufacturing Environment Cleaning