Senior Quality Engineer – Design Assurance

Senior Quality Engineer – Design Assurance

Requirements

• Bachelor’s Degree in Engineering, Science, or related field
• Minimum 5 years’ experience
• Understanding of medical device Quality System requirements including 21CFR820, ISO13485, and ISO14971
• Strong technical skills with ability to provide solutions to a variety of technical problems of moderate scope and complexity
• Demonstrated experience and understanding in use of statistical tools
• Able to independently manage projects and lead cross functional teams
• Strong writing and verbal communication skills and ability to multi-task in fast paced environment

Responsibilities

• Lead cross functional project teams as needed to accomplish quality objectives.
• Review and approve Quality System documentation in compliance with SeaSpine’s procedures, cGMP requirements and statutory requirements (US FDA, ISO, MDD and MDR) including protocols, technical reports, validation/quality plans, standard operating procedures, risk analysis, design control documents, drawings and specifications
• Facilitate the launching of new products, and the transfer of technology from development to commercialization from a Quality perspective
• Develop Design History File deliverables to support timely product launches while ensuring compliance with Quality System and Design Controls principles.
• Lead Risk Management activities and ensures that appropriate Risk Management tools (AFMEA/DFMEA/PFMEA) are utilized and consistent with applicable regulatory standards.
• Review outputs of Risk Analyses and lead cross-functional efforts to identify appropriate risk mitigation activities.
• Support sustaining activities, Quality Control and Calibration department:
• Develop and maintain inspection plans using appropriate methodologies to ensure products meet specification and are safe/effective for use
• Facilitate MRB activities as assigned by QA management
• Support Calibration and Preventive Maintenance activities.
• Conduct Out of Tolerance investigations.
• Develop statistically based sampling plans for in-process and final testing and inspections, and validations.
• Interface with contract manufacturers to develop inspection techniques and support non-conformance investigations
• Use quality engineering tools for problem solving (e.g. DMAIC, SPC, DOE).
• Identify and implement opportunities for continuous improvement. Interact and coordinate activities with other departments, external vendors and customers. Assist or lead in the prompt implementation of Quality related projects including:
• Non-Conformance resolution, Complaint Investigation and Corrective & Preventative Action(s) (CAPA), Process Validations
• Development and implementation of new and updated Quality System procedures for ISO/QSR compliance.
• Create/support special in-house and supplier validations (cleaning, water system, sterilization, software validations…).
• Lead or support equipment and process validation activities using IQ, OQ, PQ methodology.
• Prepare information for Quality Management Reviews and Operational Reviews such as: Trend charts, Pareto Analysis, etc., as required
• Participate in FDA inspections, ISO Certification and Surveillance audits and customer audits.

Preferred Qualifications

• ASQ Certifications Preferred
• Minimum 1 year working in the medical device industry is preferred.