Quality Systems Specialist Affera Software

Software Quality Systems Specialist

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

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.

Travel Requirement: <20%

Required Qualifications

• 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.

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.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.?

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

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Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):$75,200.00 - $112,800.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work