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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Quality Systems Specialist - Affera Software - **Company:** Medtronic Inc. - **Location:** Mounds View, MN, United States - **Salary:** $75,200.0 - $112,800.0 - **Contract:** Temporary contract - **Skills:** Agile Methodology, JIRA, Software Quality, Cyber Security, Document Management Systems, Software Engineering, Software Requirements Analysis, Software Security, Documentation System, Performance Monitor, Trackwise, GXP - **Published:** July 4, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=2578ffb1fb42f873 ## About the Role * Bachelor's degree and a minimum of 2 years of relevant experience * OR advanced degree with a minimum of 0 years of relevant experience Preferred Qualifications * Experience working in a regulated environment, preferably medical devices, pharmaceutical, biotechnology, or another quality system-controlled industry. * Experience supporting quality system records, documentation, process execution, or compliance activities. * Strong written and verbal communication skills, including the ability to document quality system rationale clearly and accurately. * Strong organizational skills with the ability to track multiple deliverables, follow up on action items, and support timely closure of quality system activities * Working knowledge of medical device quality system requirements and standards, including FDA 21 CFR 820, ISO 13485, IEC 62304, IEC 62366, 21 CFR Part 11, EU MDR, AAMI TIR57, FDA Software and Cybersecurity Guidance documents, and/or internal quality system requirements. * Experience supporting CAPA activities, including root cause investigation, corrective and preventive action planning, execution tracking, and verification of effectiveness. * Experience supporting field corrective actions or other post-market quality system activities. * Experience working with software products, software quality, software development lifecycle processes, or software-related investigations. * Experience with quality system documentation tools, CAPA systems, issue management systems, or product lifecycle documentation systems such as TrackWise , Agile PLM, JIRA, or similar tools. * Experience supporting audit preparation, audit observation responses, inspection readiness, or closure of audit findings. * Ability to interpret procedures and regulatory requirements and apply them to practical quality system execution. * Experience developing or supporting quality metrics, dashboards, management review inputs, or KPI tracking. * Strong analytical and decision-making skills. * Strong interpersonal skills with the ability to work constructively across Quality, R&D, Regulatory, Medical Safety, Field, Enterprise, and business teams. * Experience with process improvement methods, quality tools, or structured problem-solving techniques. * Familiarity with cardiac electrophysiology products, capital equipment, or complex medical device software. #LI-MDT For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. ## Description At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We're working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. In this role as a Software Quality Systems Specialist, you will support quality system execution for Affera software products within the Cardiac Ablation Solutions Operating Unit. This role will focus on software-related CAPAs, field corrective action execution and follow-up, quality system compliance, process support, and metric tracking. You will work closely with Quality, R&D, Regulatory, Medical Safety, Service, Enterprise teams, and other cross-functional partners to ensure software-related quality system records are complete, timely , audit-ready, and aligned with internal procedures and external regulatory expectations. This position is intended for a quality systems professional with strong compliance discipline, good technical judgment, and the ability to manage multiple quality system deliverables in a complex medical device software environment. Primary Responsibilities * Leads on-going audit and inspection readiness for software quality system areas, including CAPA records, field action records, metrics, procedures, and related objective evidence. * Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to ensure compliance. * Supports Changing Regulation Notification assessments for software-related areas. * Support execution of software-related CAPAs, including organization and education of CAPA owners, action tracking, documentation review, implementation support, and support for verification of effectiveness activities. * Support field corrective action execution for Affera software, including coordination of action items, follow-up activities, evidence collection, and status tracking. * Partner with Software Quality, R&D, Regulatory, Medical Safety, Product Security, Customer Quality, and Field Quality teams to support timely and compliant resolution of software-related quality systems and procedural issues. * Maintain and track metrics related to software and security CAPAs, field actions, quality system deliverables, action item closure, and other software quality indicators, preparing weekly reports and management review inputs. * Support review of and changes to quality system records for completeness, consistency, traceability, and compliance with internal procedures and regulatory expectations. * Work directly with cross-functional teams to provide process oversight, reinforce quality system requirements, and support compliant execution of assigned deliverables. * Assist with closure of audit findings, corrections, corrective actions, and preventive actions related to software quality system processes. * Support software-related quality system integration and stabilization activities as processes, tools, and procedures scale to support larger field usage and continue to align with Medtronic requirements. * Identify opportunities to improve quality system execution, documentation quality, metric visibility, and process effectiveness for software quality activities. ## Related Videos - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) - [Improving quality with Agentic AI with Rovo Dev and Xray](https://www.wearedevelopers.com/videos/2005-improving-quality-with-agentic-ai-with-rovo-dev-and-xray) - [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips) - [Collaboration Quantified: Lessons from Open Source Developer Networks](https://www.wearedevelopers.com/videos/1422-collaboration-quantified-lessons-from-open-source-developer-networks) - [From Bedside Beeps to Interoperable Bytes – Getting your medical devices ready to talk the IEEE 11073 language](https://www.wearedevelopers.com/videos/771-from-bedside-beeps-to-interoperable-bytes-getting-your-medical-devices-ready-to-talk-the-ieee-11073-language) - [Integrate your Cognitive Assistant with 3rd-party DBs and software](https://www.wearedevelopers.com/videos/249-integrate-your-cognitive-assistant-with-3rd-party-dbs-and-software) ## Related Articles - [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers) - [Where to Find Entry-Level Software Engineering Jobs](https://www.wearedevelopers.com/magazine/397-where-to-find-entry-level-software-engineering-jobs) - [Top-Paying Tech Jobs (with Salaries)](https://www.wearedevelopers.com/magazine/372-top-paying-tech-jobs-with-salaries) - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs) - [Is Software Engineering Over-Saturated?](https://www.wearedevelopers.com/magazine/418-is-software-engineering-over-saturated) - [Where To Find Software Engineering Jobs](https://www.wearedevelopers.com/magazine/396-where-to-find-software-engineering-jobs)