Description
Description:
- A Senior Quality Engineer within our Emergency Care and Resuscitation (ECR) team is responsible in developing and implementing systems to ensure products or services are designed and produced to meet or exceed customer requirements and expectations. The engineer participates in the cross-functional change management process to assure the products or services continue to meet customer requirements
- The engineer provides independent oversight and review of the project deliverables throughout the product lifecycle. Provides leadership and is responsible and accountable to the organization for own decisions and actions, while also holding others accountable for the same. This position will have a focus on software based quality assurance both in design and manufacturing
Responsibilities:
- Ensures that appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design with an emphasis on software validation and design controls
- Validates key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs
- Provides effective oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product/system lifecycle with an emphasis on software
- Performs independent technical assessment on product quality performance and post-market product quality analysis
- Can Lead quality related problem solving and root cause analysis during design and manufacturing
- Act as a single point of contact (person assigned to project team) responsible to ensure that software based design meets quality and compliance standards for every milestone
- Function as a local subject matter expert on software validation techniques and management of electronic records and signatures
- Provide leadership and oversight to ensure Quality Management System Compliance
Skills and Experience:
- Engineering Degree or equivalent experience in medical device industry
- 5+ years' experience with a medical device company
- ASQ Certified Quality Engineer
- Working knowledge of C#, Java, Python, or other managed programming language
- Have an understanding of quality philosophies, principles, systems, methods, tools, standards, organizational and team dynamics, customer expectations and satisfaction, supplier relations and performance, leadership, training, interpersonal relationships, improvement systems, and professional ethics
- Have understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements
- Be able to develop and implement quality programs, including tracking, analysing, reporting, and problem solving
- Be able to plan, control, and assure product and process quality in accordance with quality principles, which include planning processes, material control, acceptance sampling, and measurement systems
- Multiple years of experience working in a software design and quality assurance environment
- Demonstrable experience validating software in a manufacturing environment