Sr Quality Engineer – Electronics

Sr Quality Engineer – Electronics

Requirements

• Bachelor’s degree in Engineering, a Life Science or related field with 5+ years of relevant experience, including experience in Quality Assurance and ISO, or an equivalent combination of education and experience, preferably in a medical devices’ or regulated industry environment

Responsibilities

• Participate in the development and qualification activities for new and existing products.
• Lead and participate in project teams coordinating the quality efforts to design, develop, and continuously improve products. Plan, schedule, conduct, or coordinate detailed phases of the engineering work for projects with various scopes.
• Perform work which involves conventional engineering practice but may include a variety of complex features, such as conflicting design requirements, unsuitability of standard materials, and difficult coordination requirements.
• Perform engineering work including one or more of the following: Design and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of equipment.
• Develop and validate measurement methods.
• Monitor design control to assure that new products meet guidelines, develop success measurements, and maintain currency with design control standards per regulatory and industry standards.
• Support developmental projects in the area of quality assurance.
• Analyze reports and returned products and recommend corrective and preventive action.
• Perform statistical analysis and determine the responsibility for products or materials that do not meet required standards and specifications.
• Participate in NCR or CAPA board as necessary.
• Assist in and perform QSR training.
• Support activities during FDA inspections, FDB inspections, and notified body audits.
• Participate in the development of standard operating procedures.
• Prepare documentation for inspection/testing procedures.
• Perform responsibilities required by the Quality System and other duties as assigned.
• Select, manage, train, and develop staff. Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans.
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
• Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.
• Ensure other members of the department follow the QMS, regulations, standards, and procedures.

Preferred Qualifications

• Advanced degree preferred
• Experience in auditing, design review, sterilization, project management, and/or product development highly desired
• Experience with Electronic devices and or PCBAs
• Experience with Contract Manufactured Electromechanical Medical device products