Who we want
Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
What you will do
As a Senior Quality Engineer, you will develop and implement methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed. You will design and install sophisticated testing equipment and perform product testing and analysis to maintain quality levels and minimize defects and failure rates. Analyzes reports and defective products to determine trends and recommend corrective actions. Collaborates with supplier representatives on quality problems, ensures that effective corrective actions are implemented and contributes to supplier quality improvement programs.
Work closely with operations and the business functions to ensure quality performance of product and processes.
Collaborates with Divisional QA, cross-functional and suppliers teams to address top quality issues.
Own identified internal and supplier driven non-conformances and manage the timely closure of NC's within Trackwise.
Own or support identified internal CAPAs and manage to timely root cause investigation, implementation and closure.
Disposition non-conforming product within MRB, issuing NC's as appropriate.
Communicate & collaborate with suppliers regarding non-conformances, escalating supplier corrective action requests as required.
Engage in the development and improvement of the internal manufacturing processes for existing products.
Performs critical assessment of internal and supplier proposed change management activities.
Performs PPAP activities for supplier changes.
Participates and may lead in the creation and/or review of new or modified procedures.
Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.
Support execution and analysis of manufacturing related complaints and product field actions.
Support and Drive Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.
Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification.
Develop understanding of risk management practices and concepts and applies knowledge to manufacturing operations.
Support the creation and maintenance of inspection methods and sampling.
Applies statistical methods of analysis and process control to current operations.
Engage and interface in internal and external audits providing subject matter expertise
Support the development and review of process and equipment validation/qualification and MSA of internal processes.
Execute internal quality deliverables associated with engineering changes, manufacturing transfers and supplier-initiated changes.
Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
Responsible for initiation, internal containment, communication and support of Commercial Holds for potential product escapes.
What you need
Bachelors Degree in Engineering is required.
Minimum 2+ years' experience working in quality, manufacturing, engineering or in a highly regulated environment.
Knowledge and understanding of US and International Medical Device Regulations.
Strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.
Demonstrated ability to successfully manage and complete projects in a matrix organization.
Demonstrated ability to work independently.
Experience in working in a compliance risk situation.