Quality Investigations Engineer

What You Will Do: 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 Remote Work Eligibility. Allowed up to 2 days per week in accordance with policy Management: For those who manage or supervise staff: 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 Bachelor of Science (B.S.) in Engineering or equivalent experience 2+ years in Medical Device or similar experience

Preferred Qualifications: 2 years in a quality role ASQ Certification as a Quality Engineer or equivalent Upon Hire Technical & Functional Skills 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. Comprehensive Medical, Dental, and Vision plans 20 days of Paid Time Off 15 paid holidays 401(k) And more! Your benefits and PTO start the date you're hired with no waiting period! This position is not eligible for employer-sponsored work authorization. Applicants must be legally authorized to work in the United States without the need for current or future employer-sponsored work authorization. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.