Quality Systems Specialist – Affera Software

Medtronic•Mounds View, MN

1d•$75,200 - $112,800•Hybrid

About The Position

We are seeking a Software Quality Systems Specialist to support the 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 collaborate 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 ideal 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.

Requirements

Bachelor's degree and a minimum of 2 years of relevant experience OR advanced degree with a minimum of 0 years of relevant experience

Nice To Haves

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.

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.

Benefits

Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)