Sr. Quality Engineer (Must Have Exp @ MFG Facility with MFG Operations)

Summary/Purpose of Position

Seeking a Sr Quality Engineer or Sr Mfg Engineer with Medical Device experience (Class III preferred), strong compliance background, that has worked at a manufacturing site and is familiar with Quality and Operations remediation. Depth of experience with CAPAs, root cause analysis, problem solving, development of permanent/systemic solutions, and implementation execution are all critical for this role.

Essential Duties and Position Responsibilities

• 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 (MasterControl), and 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 of CAPA effectiveness will be required as well.

Qualifications, Knowledge, and Skills Required

• Engineering BS Degree with minimum of 5 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 technical assignments with command and leadership, specifically for quality and manufacturing issue resolution and remediation.
• 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) preferred

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