Support field corrective action execution for Affera software, including coordination of action ... Experience with quality system documentation tools, CAPA systems, issue management systems, or ...
New
Support field corrective action execution for Affera software, including coordination of action ... Experience with quality system documentation tools, CAPA systems, issue management systems, or ...
New
Support field corrective action execution for Affera software, including coordination of action ... Experience with quality system documentation tools, CAPA systems, issue management systems, or ...
New
Support field corrective action execution for Affera software, including coordination of action ... Experience with quality system documentation tools, CAPA systems, issue management systems, or ...
New
Support field corrective action execution for Affera software, including coordination of action ... Experience with quality system documentation tools, CAPA systems, issue management systems, or ...
New
Support field corrective action execution for Affera software, including coordination of action ... Experience with quality system documentation tools, CAPA systems, issue management systems, or ...
New
Support field corrective action execution for Affera software, including coordination of action ... Experience with quality system documentation tools, CAPA systems, issue management systems, or ...
New
The role will report to the Sr. Manager for Affera Capital (HW) Reliability Engineering team. About the Affera Mapping and Ablation System The Affera Mapping and Ablation System is an innovative ...
The role will report to the Sr. Manager for Affera Capital (HW) Reliability Engineering team. About the Affera Mapping and Ablation System The Affera Mapping and Ablation System is an innovative ...
The role will report to the Sr. Manager for Affera Capital (HW) Reliability Engineering team. About the Affera Mapping and Ablation System The Affera Mapping and Ablation System is an innovative ...
The role will report to the Sr. Manager for Affera Capital (HW) Reliability Engineering team. About the Affera Mapping and Ablation System The Affera Mapping and Ablation System is an innovative ...
The role will report to the Sr. Manager for Affera Capital (HW) Reliability Engineering team. About the Affera Mapping and Ablation System The Affera Mapping and Ablation System is an innovative ...
The role will report to the Sr. Manager for Affera Capital (HW) Reliability Engineering team. About the Affera Mapping and Ablation System The Affera Mapping and Ablation System is an innovative ...
The role will report to the Sr. Manager for Affera Capital (HW) Reliability Engineering team. About the Affera Mapping and Ablation System The Affera Mapping and Ablation System is an innovative ...
The role will report to the Sr. Manager for Affera Capital (HW) Reliability Engineering team. About the Affera Mapping and Ablation System The Affera Mapping and Ablation System is an innovative ...
The role will report to the Sr. Manager for Affera Capital (HW) Reliability Engineering team. About the Affera Mapping and Ablation System The Affera Mapping and Ablation System is an innovative ...
The role will report to the Sr. Manager for Affera Capital (HW) Reliability Engineering team. About the Affera Mapping and Ablation System The Affera Mapping and Ablation System is an innovative ...
About the Affera Mapping and Ablation System The Affera Mapping and Ablation System is an ... Ability to manage, track and upgrade multiple hardware and software configurations. * Ability to ...
About the Affera Mapping and Ablation System The Affera Mapping and Ablation System is an ... Ability to manage, track and upgrade multiple hardware and software configurations. * Ability to ...
Moundsview, MN · On-site
$70 - $80/hr
About the Affera Mapping and Ablation System The Affera Mapping and Ablation System is an ... Ability to manage, track and upgrade multiple hardware and software configurations. * Ability to ...
Moundsview, MN · On-site
$70 - $80/hr
About the Affera Mapping and Ablation System The Affera Mapping and Ablation System is an ... Ability to manage, track and upgrade multiple hardware and software configurations. * Ability to ...
About the Affera Mapping and Ablation System The Affera Mapping and Ablation System is an ... Ability to manage, track and upgrade multiple hardware and software configurations. * Ability to ...
About the Affera Mapping and Ablation System The Affera Mapping and Ablation System is an ... Ability to manage, track and upgrade multiple hardware and software configurations. * Ability to ...
Newton, MA · On-site
$121K - $157K/yr
TheSenior SoftwareTest Engineerwillbe anintegral memberin the Affera Software Team, working ... Experience using a tool or repository for managing test cases (Polarion, TFS, TestRail, JAMA etc
Newton, MA · On-site
$121K - $157K/yr
TheSenior SoftwareTest Engineerwillbe anintegral memberin the Affera Software Team, working ... Experience using a tool or repository for managing test cases (Polarion, TFS, TestRail, JAMA etc
Join Medtronic as an Affera Mapping Specialist and be at the forefront of transforming lives ... Work in partnership with Account Manager, Regional Manager and Area Directors to identify potential ...
Join Medtronic as an Affera Mapping Specialist and be at the forefront of transforming lives ... Work in partnership with Account Manager, Regional Manager and Area Directors to identify potential ...
Moundsview, MN · On-site
$108K - $136K/yr
The role will report to the Sr. Manager for Affera Capital (HW) Reliability Engineering team. Primary Responsibilities * Develops, coordinates and conducts technical reliability studies and ...
New
Moundsview, MN · On-site
$108K - $136K/yr
The role will report to the Sr. Manager for Affera Capital (HW) Reliability Engineering team. Primary Responsibilities * Develops, coordinates and conducts technical reliability studies and ...
New
Join Medtronic as an Affera Mapping Specialist and be at the forefront of transforming lives ... Work in partnership with Account Manager, Regional Manager and Area Directors to identify potential ...
Join Medtronic as an Affera Mapping Specialist and be at the forefront of transforming lives ... Work in partnership with Account Manager, Regional Manager and Area Directors to identify potential ...
About the Affera Mapping and Ablation System The Affera Mapping and Ablation System is an ... Ability to manage, track and upgrade multiple hardware and software configurations. * Ability to ...
About the Affera Mapping and Ablation System The Affera Mapping and Ablation System is an ... Ability to manage, track and upgrade multiple hardware and software configurations. * Ability to ...
Moundsview, MN · On-site
$117K - $152K/yr
Once identified, the Affera Ablation System delivers targeted energy to disrupt these abnormal ... Experience using a tool or repository for managing test cases (Polarion, TFS, TestRail, JAMA etc
Moundsview, MN · On-site
$117K - $152K/yr
Once identified, the Affera Ablation System delivers targeted energy to disrupt these abnormal ... Experience using a tool or repository for managing test cases (Polarion, TFS, TestRail, JAMA etc
Moundsview, MN · On-site
$117K - $152K/yr
TheSenior SoftwareTest Engineerwillbe anintegral memberin the Affera Software Team, working ... Experience using a tool or repository for managing test cases (Polarion, TFS, TestRail, JAMA etc
Moundsview, MN · On-site
$117K - $152K/yr
TheSenior SoftwareTest Engineerwillbe anintegral memberin the Affera Software Team, working ... Experience using a tool or repository for managing test cases (Polarion, TFS, TestRail, JAMA etc
About the Affera Mapping and Ablation System The Affera Mapping and Ablation System is an ... Ability to manage, track and upgrade multiple hardware and software configurations. * Ability to ...
About the Affera Mapping and Ablation System The Affera Mapping and Ablation System is an ... Ability to manage, track and upgrade multiple hardware and software configurations. * Ability to ...
About the Affera Mapping and Ablation System The Affera Mapping and Ablation System is an ... Ability to manage, track and upgrade multiple hardware and software configurations. * Ability to ...
About the Affera Mapping and Ablation System The Affera Mapping and Ablation System is an ... Ability to manage, track and upgrade multiple hardware and software configurations. * Ability to ...
| Aspect | Manager Affera | Manager Cerner |
|---|---|---|
| Required Certifications | Certifications in Affera platform, project management, or healthcare IT | Certifications in Cerner Millennium, healthcare IT, or project management |
| Work Environment | Healthcare technology companies, hospitals implementing Affera systems | Hospitals, clinics, healthcare organizations using Cerner systems |
| Industry Usage | Primarily in healthcare technology and medical device integration | Widely used in healthcare IT and electronic health record management |
Both Manager Affera and Manager Cerner roles focus on healthcare IT management but differ in platform specialization. Manager Affera specializes in managing Affera's healthcare technology solutions, while Manager Cerner oversees Cerner-based systems. The choice depends on the specific technology used by the employer and the certifications held by the professional.

Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Posted 5 days ago
New
7.8
Based on 169 frontline employees who took The Breakroom Quiz
171st of 527 rated manufacturers
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.
A Day in the LifeAt 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 andinspectionreadiness for software quality system areas, including CAPA records, field action records, metrics, procedures, and related objective evidence.
Providesexpertiseand guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to ensure compliance.
Supports Changing RegulationNotificationassessments 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 supporttimelyand 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.
Assistwith 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.
Identifyopportunities to improve quality system execution, documentation quality, metric visibility, and process effectiveness for software quality activities.
Travel Requirement: <20%
Required Qualifications
Bachelor's degree anda minimum of2years of relevant experience
ORadvanceddegree witha minimum of0years 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 supporttimelyclosure 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, softwaredevelopmentlifecycle processes, or software-related investigations.
Experience with quality system documentation tools, CAPA systems, issue management systems, or product lifecycle documentation systems such asTrackWise, Agile PLM, JIRA, or similar tools.
Experience supporting audit preparation, audit observation responses,inspectionreadiness, 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.
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.
Recruitment Fraud Alert
We are aware of phishing scams targeting job seekers. Please keep the following in mind:
Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.
Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.
If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.
If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com.
Benefits & CompensationMedtronic 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.
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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, andSimple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: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), andCapital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
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