Quality Engineer I
MedtronicAbout the role
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
Across our global Neuroscience organization, we advance care for some of medicine’s most complex neurological and spinal conditions. By combining innovative technology, data-driven insights, and deep clinical expertise, we partner with physicians and health systems to improve how patients are treated and supported throughout their care journey.
Our Cranial & Spinal Technologies (CST) operating unit advances surgical care for spine and cranial conditions through an integrated ecosystem of implants, navigation, robotics, imaging, and planning tools. Platforms like AiBLE enhance precision, efficiency, and outcomes for complex procedures worldwide.
Check us out on LinkedIn: Medtronic CST
Onsite
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary.
Responsibilities may include the following and other duties may be assigned:
Develops, modifies, applies, and maintains quality standards, processes and procedures within the Quality Management Systems
Collaborates across functions to ensure quality standards are in place and upholds requirements to ensure product quality by following established quality processes and documentation standards.
Develops overall criteria to ensure implementation of the software QMS according to process, project, and contract requirements. Ensures that the documentation is compliant with requirements and contracts. Reviews software design controls deliverables: including requirements, specifications, tools, and methodologies, verification and validation of software system requirements, traceability, and testability to support the user of the software.
Collaborate with developers, product owners, and internal users to triage issues, clarify expected behavior, and support defect resolution
Ensures that corrective measures meet acceptable standards and that documentation is compliant with procedural requirements
Support NC/CAPA QMS processes and requirements
Engage in ongoing learning of cloud technologies, application architecture, tools, and quality engineering practices to expand responsibilities over time.
As Quality Engineer I you will:
Maintain and update quality documentation for medical and nonmedical device software to support the software user Clinic Team; including software development NPI and release product management RPE support
Ensure accuracy, completeness, and adherence with processes and procedures ensuring that Quality System Requirements are met.
Maintain document control activities within the Quality Management system including procedures, work instructions, forms, and supporting documents
Support NC/CAPA including; initiation, investigation and root cause analysis, corrective actions, and effectiveness of CAPA solutions
Support defect management review and disposition activities including defect escalation (when necessary)
Perform complaint investigations supporting the software clinic team and document findings and ensure timely and accurate closure.
Drive continuous improvement of processes and activities supporting the Clinic Team within the Quality Engineering role.
Drive Quality through engagement with cross-functional teams involved in software development and software surgical planning.
Must Have: Minimum Requirements:
Requires a Bachelors degree in a technical related field
Nice to Have: Preferred Qualifications:
Engineer Degree
1-4 years of industry experience
Medical Device experience
Software knowledge and understanding
Design Quality Engineering
NC/CAPA
Defect resolution
Experience in a regulated industry or related health care field.
For Baccalaureate degrees earned outside
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