Quality Engineer

Job Description

Quality Engineer is responsible for supporting and maintaining quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established standards and agency regulations.  Uses problem solving, technical writing, and communication skills to gather cross functional buy in for improvements ranging from relatively simple to significant in terms of scope and impact. Applies a structured methodical approach even in dynamic situations with significant uncertainty and supports projects through to completion.

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Initiates and completes technical activities leading to new or improved products or process, for current programs, next generation programs and to meet strategic goals and objectives of the company. 
• Prepares reports, publishes, and makes presentations to communicate findings.  
• Analyzes and solves problems from basic engineering principles, theories, and concepts through to a wide range of complex and advanced problems which require novel and new innovative approaches or a major breakthrough in technology.
• Understands and can apply engineering principles theories, concepts, practices, and techniques. 
• Develops knowledge in a field to become a recognized leader or authority in an area of specialization and applies this knowledge in leadership roles in the company.
• Incorporates business policies and procedures into task completion.
• Cultivates internal and external network of resources to complete tasks.
• Builds strategic partnerships with internal and external stakeholders to further departmental and organizational objectives.
• Supports project team, determining goals and objectives for the projects.
• Recommends and implements changes to the system as the result of changing regulations and/or business needs.
• Analyzes data, makes decisions or provides recommendations to senior staff regarding quality related crises (e.g. patient injury due to product malfunction).
• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
• Identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

This JD is for a Quality / Regulatory Engineering role in medical devices (or another highly regulated life‑sciences product area). It focuses on Quality Management Systems, regulatory compliance (FDA 21 CFR 820, ISO 13485), risk reduction, CAPA, design/process controls