Medical Device Quality Engineer

We're looking for an engineer with a strong attention to detail to help us build out our QMS system.

You will be leading, supporting and ensuring continued suitability of the Quality Management System (QMS) with a primary focus on design control, risk management, post-market surveillance, CAPA, complaints, auditing, supplier/manufacturing management, system validation, NCM/MRB, change control, document control and training; This position will also support other areas of the Quality Assurance department and additional tasks determined by management.

**To be considered, please reply to this job with the subject line: I want to work for you (enter the name of the university found on our homepage).**

Responsibilities:
• Lead the planning, design, preparation, execution, reporting, and analysis of design verification and validation efforts to approve equipment, systems, processes, and software used in the testing, processing, manufacturing, storing, and distribution of products
• Support the creation and implementation of corporate policies and procedures relating to quality, project management, process development, and FDA/ISO compliance
• Manage and maintain risk management files for multiple devices ensuring risk activities occur as required
• Coordinate and/or lead Post-Market Surveillance activities
• Oversee the Corrective / Preventive Action (CAPA), Change Control and NCM/MRB systems
• Complete evaluations, reporting, and resolution of product complaints
• Generate annual Audit Plan; manage, schedule, perform and report on internal and supplier audits
• Maintain Approved Supplier List
• Lead regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design, manufacturing quality and compliance to QSR/ISO requirements
• Provide guidance to management on tools, techniques and systems for quality assurance, compliance, and continuous quality improvement
• Assist in training company employees on the principles of Quality and other QMS elements

REQUIREMENTS:
• BS/BA (MS preferred) in science or technical field (engineering preferred) and 5 years Quality Assurance experience with medical devices
• Strong Quality background in analysis, problem solving, process validation, risk management and statistical techniques
• Project management experience
• Strong CAPA experience is required
• Effective time management, planning and organizational skills, with the ability to multi-task in a fast-paced environment
• Broad project and process knowledge with medical devices
• Previous participation in regulatory audits / FDA inspections
• Experience with Document Control procedures / creation and processing of Change Orders
• Excellent interpersonal and communication skills required to work effectively with all levels of staff
• Ability to clearly present written information and findings at an executive level
• Must be a self-starter and team player able to work with minimum supervision among all levels in the organization
• Computer proficiency required in Excel, PowerPoint, Word