Spacelabs Healthcare
Sr. Quality Assurance Engineer (Cloud Systems)
Spacelabs Healthcare, Oklahoma City, Oklahoma, United States, 73116
Overview
At Spacelabs Healthcare, you make a difference. Every member of our worldwide team is integral in improving treatment and helping providers deliver exceptional care to their patients. From newborns to centenarians, more than 60 million people benefit yearly from the advancements we make in patient monitoring and management, care coordination, and clinical decision support. Driven by the belief that anyone who seeks care could be a member of our own family, our team is dedicated to solving the greatest challenges the healthcare system currently faces, including the need to enhance the patient experience, improve population health, reduce costs, support care team well-being, and advance health equity. As part of our mission, we take pride in creating services and technologies that are personalized and tailored to support the needs of healthcare providers anywhere in the world. While we may not be at a patient's bedside, their health is still in our hands. Position
The Sr. Quality Assurance Engineer (Cloud Systems) shall provide leadership and support for QMS performance in many facets of business operations. This role is based in the Oklahoma City, OK office. Responsibilities
Design Control:
Ensure the release of safe, effective, and compliant medical devices by mentoring in Quality System Design Control, reviewing engineering change orders, and ensuring timely and proper documentation. Manufacturing:
Monitor and ensure efficient product manufacturing processes, including work instructions, material control, and inspection. Material Review Board:
Facilitate processing of Nonconforming Material Reports and Rework Orders, monitoring process performance metrics. Installation and Service:
Ensure post-market activities support device performance, document support activities, and assess product performance trends for improvement. QMS Administration:
Conduct internal audits, manage CAPA, process changes, supplier quality, and support external audits. Collaborate with teams to maintain compliance with standards like ISO 13485, MDR, MDSAP, and others. Support regulatory submissions and participate in cross-functional design reviews. Additional duties:
Create and update quality procedures, support manufacturing and design teams, review and approve device history records, perform floor walkthroughs, and support continuous improvement initiatives. Qualifications
Bachelor's degree in Quality, Engineering, or related field. 7+ years of relevant Quality/Engineering experience. 5+ years experience with medical device QMS and regulations. 2+ years working with cloud product systems. Experience with technical documentation and statistical analysis. Knowledge of SaMD or software within medical devices. Desirable Skills
Experience as a Change Agent. Familiarity with FDA regulations, ISO standards, and cybersecurity. Creative problem-solving and negotiation skills. Willingness to travel domestically and internationally (
Additional Information
Review our benefits at Life at OSI. Salary is based on experience and market considerations. Note: OSI Systems does not accept unsolicited resumes from recruiters or agencies without a signed agreement. We are an equal opportunity employer committed to diversity and inclusion. #J-18808-Ljbffr
At Spacelabs Healthcare, you make a difference. Every member of our worldwide team is integral in improving treatment and helping providers deliver exceptional care to their patients. From newborns to centenarians, more than 60 million people benefit yearly from the advancements we make in patient monitoring and management, care coordination, and clinical decision support. Driven by the belief that anyone who seeks care could be a member of our own family, our team is dedicated to solving the greatest challenges the healthcare system currently faces, including the need to enhance the patient experience, improve population health, reduce costs, support care team well-being, and advance health equity. As part of our mission, we take pride in creating services and technologies that are personalized and tailored to support the needs of healthcare providers anywhere in the world. While we may not be at a patient's bedside, their health is still in our hands. Position
The Sr. Quality Assurance Engineer (Cloud Systems) shall provide leadership and support for QMS performance in many facets of business operations. This role is based in the Oklahoma City, OK office. Responsibilities
Design Control:
Ensure the release of safe, effective, and compliant medical devices by mentoring in Quality System Design Control, reviewing engineering change orders, and ensuring timely and proper documentation. Manufacturing:
Monitor and ensure efficient product manufacturing processes, including work instructions, material control, and inspection. Material Review Board:
Facilitate processing of Nonconforming Material Reports and Rework Orders, monitoring process performance metrics. Installation and Service:
Ensure post-market activities support device performance, document support activities, and assess product performance trends for improvement. QMS Administration:
Conduct internal audits, manage CAPA, process changes, supplier quality, and support external audits. Collaborate with teams to maintain compliance with standards like ISO 13485, MDR, MDSAP, and others. Support regulatory submissions and participate in cross-functional design reviews. Additional duties:
Create and update quality procedures, support manufacturing and design teams, review and approve device history records, perform floor walkthroughs, and support continuous improvement initiatives. Qualifications
Bachelor's degree in Quality, Engineering, or related field. 7+ years of relevant Quality/Engineering experience. 5+ years experience with medical device QMS and regulations. 2+ years working with cloud product systems. Experience with technical documentation and statistical analysis. Knowledge of SaMD or software within medical devices. Desirable Skills
Experience as a Change Agent. Familiarity with FDA regulations, ISO standards, and cybersecurity. Creative problem-solving and negotiation skills. Willingness to travel domestically and internationally (
Additional Information
Review our benefits at Life at OSI. Salary is based on experience and market considerations. Note: OSI Systems does not accept unsolicited resumes from recruiters or agencies without a signed agreement. We are an equal opportunity employer committed to diversity and inclusion. #J-18808-Ljbffr