Careers that Change Lives
This position will be accountable for leading design quality activities in new product development, moving with speed and decisiveness to ensure on time delivery of products with the highest standards of quality. Acting boldly in collaboration with the product development team, primary responsibilities will include; progressing the design controls, planning and tracking of quality activities, ensuring establishment of appropriate manufacturing processes & controls. To formulate, deliver and/or manage projects assigned and work with other stakeholders to achieve desired results. The majority of time will be spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.
A day in the life
Design Quality Assurance Accountable for the execution of design quality related activities in new product development projects by providing design quality engineering services to advance existing technology or introduce new technology and therapies. Ensure defendable engineering and scientific analyses are employed and quality documentation (design history files) comply with company policies and governmental regulations. Review specifications to evaluate quality requirements including identification of key characteristics for inspection plans and methods.
Design Controls/Quality System Conduct investigations to identify root cause of problems and implement effective corrective actions, including corrective and preventive actions Identify areas for ongoing optimization and simplification of quality system procedures.
Production and Process Controls Understand and apply the manufacturing quality toolset for support to production processes. Assist manufacturing entities with the interpretation of quality requirements including process verification/validation planning and execution, first production run requirements and problem resolution. Support development of control plans that identify inspection characteristics, gauging techniques, and sampling requirements.
BA or Master in Quality engineering
5 to 7 years of Experience in the medical device industry and related regulations and international standards; ISO 13485, CFR 820, ISO 14971 and other regulations that may apply
Fluent in English.
Proficient with Microsoft Office (Word, Excel, PowerPoint)
Ability to work effectively in a globally diverse team environment and build strong working relationships.
Travel no less than 25% of the role.
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
# Li-Remote Additional Information
Posting Date: Jul 14, 2021
Travel: Yes, < 25 % of the Time