Do you want to join us in helping to fight the world’s most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
At Siemens Healthineers, we offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally.
Our Global Team:
We are a team of more than 72,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.
Our Culture:
We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.
As the Sr Product Quality Engineer, you will lead the efforts in designing, implementing, and maintaining quality assurance protocols and methods for processing materials into subassemblies or finished products. In this role, you will be responsible for planning, implementing, and managing compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standards requirements for worldwide distribution.What You will do:
Active participation in defining activities to assure compliance to all Internal Policies and Procedures as well as to all External Standards (QSR, ISO 13485, MDSAP, MDD and EU MDR).Experience with electro-mechanical products that use software/firmware.Experience with process and software validation and the ability to develop and write protocols, validation reports, engineering reports, etc. that support product development and manufacturing process changes in compliance with design controls.Takes a leadership role in assuring all activities in the area of equipment, process and software validations meet FDA and International regulatory requirements.Active participation in the review of engineering specifications to assure that adequate quality assurance requirements are met and designs are adequately transferred into manufacturing with high process capability measured against critical to quality design output requirements.As assigned, participates in New Product Development, development of quality plans, and verification of engineering tests and measurement practices for new and existing products.Participate in design reviews to ensure adherence to design control requirements review drawings for adherence to design inputs; material callouts and standards and procedures; and regulatory and QS requirements; verify that required reports are attached so that the project can proceed to the next phase. Assist with QC inspection program development and implementation and provides daily technical support to incoming inspection personnel relating to first article inspection, sampling, and inspection plans.Participate in NC Investigations, MRB, and CAPA meetings to ensure adherence to requirements and on-time closure of NCs and CAPAs. Complete assigned to action items related to NCs or CAPAs.Assist with development of quality and operating procedures to assure alignment with current GMP/QSR, ISO, MDD and EU MDR requirements.Supports annual training to the requirements of applicable regulations and standards for all appropriate personnel as necessary.Maintaining or monitoring key production performance metrics.Participates and supports internal audits, external audits and inspections.Other activities as assigned.What You will have:
Proven experience working with and understanding Quality System requirements in the medical device industry, such as 21CFR820, ISO 13485:2016, EU MDR.Bachelor’s degree in engineering (mechanical or electrical preferred) or equivalent experience and 8 years of related experience or master’s degree with 6 years of related experience in the medical device industry.Knowledge of manufacturing processes (e.g., welding, injection molding, machining, sterilization).Background in manufacturing engineering and/or process engineering, desired.Experience with inspection test methodologies, desired.Experience with SAP or equivalent ERP and productivity software.One or more quality certifications required (e.g. ASQ – CQE, CQA, CBA). Lean Six Sigma Green Belt or higher, preferred.#LS-OS1
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
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As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.