Location: Onsite Status Type: Full Time Shift: 3rd Shift (M-F 10:00PM-6:30AM EST) QUALIFICATIONS Required: • Bachelor’s Degree or equivalent combination of education, training, and experience • Minimum 2 years of experience in Quality Assurance for the pharmaceutical or medical device industries Preferred: • Experience in record review and material disposition • Experience in SAP preferred or equivalent ERP system Skills & Competencies: • Solid computer skills including Microsoft Office and databases/excel spreadsheets • Good communication skills – verbal and written • Understanding of Quality System requirements (i.e., nonconformances, GDP etc.) in a regulated medical device or pharmaceutical environment • Good understanding of device and/or pharmaceutical regulatory and compliance requirements • Ability to adapt to change and handle unexpected situations, requires occasional guidance. • Shows inquisitiveness about how situations are evolving and identifies how to adapt early to • changing situations. • Ability to apply competency in difficult situations. • Ability to follow defined procedures and proactively diagnose. • Ability to stay focused on tasks, organize, compare, and interpret data and assess problems with little guidance. • Ability to collaborate and maintain cooperative work relationships with others. • Engages colleagues with the Enable Values in mind. • Ability to maintain a positive attitude, show empathy for others • Ability to have a positive impact on others in support of company goals and a healthy work environment. • Strong time management skills Physical Requirements: • Must be able to remain in a stationary position for extended periods of time • Must be able to gown and work in a clean room for extended periods of time. • Ability to lift and lower boxes of documents or handle equipment weighing up to 25 lbs. • Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc. • Position requires being physically present on the premises during regular company hours or as approved by management RESPONSIBILITIES: • Performs Batch Disposition responsibilities for Materials, Components, and Sub-Assemblies • Performs routine Gemba walks and process audits on shift to verify adherence to approved procedures and work instructions. Documents and reports observations. • Serves as the Quality point of contact for shift production leads. Participates in shift handoffs and tier meetings, and passes open quality issues to other shifts. • Primary contact for production events; places product or material on hold when quality is potentially impacted, and escalates per procedure • Responsible for supporting Nonconformance programs • Assists Quality Management in providing guidance on compliance related issues • Ensures product safety, regulatory compliance, and compliance through proper management of quality documents and quality records • Develops or updates quality procedures and work instructions, when required • Identifies areas of opportunity to reduce waste and improve efficiency