Quality Systems Specialist

Medtronic

. Own and drive investigations, root cause analysis, and resulting corrective and preventive actions .

Posted 10/16/2026full-timeUnited StatesMid-LevelSenior💰 $75,200 - $112,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Management Systems (QMS) and regulatory compliance, including FDA, ISO 13485, and GMP standards. Proven ability to lead investigations, perform root cause analysis, and implement corrective actions while effectively communicating with stakeholders.

Highest-signal resume keywords

Quality Management Systems (QMS)FDA Regulatory ComplianceISO 13485 KnowledgeRoot Cause AnalysisData Analysis Tools

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality System ElementsRegulatory RequirementsDesign ControlManufacturing ProcessesTrend AnalysisProblem-Solving TechniquesAudit PreparationCorrective ActionsPreventive ActionsCompliance Observations

Soft Skills

Outstanding Written CommunicationOral Communication SkillsDecision-Making AbilityAttention to DetailLeadership Skills

Tools & Technologies

Data Analysis ToolsComputer Systems

Industry Keywords

FDAGMPQSRMDSAPHealthcare IndustryRegulatory InspectionsAuditsPolicy UpdatesHIPAAMedical Devices

About the role

Key responsibilities & impact

Own and drive investigations, root cause analysis, and resulting corrective and preventive actions
Provide Quality System support and guidance to maintain compliance with FDA and international regulatory requirements
Oversee development and maintenance of quality systems, programs, processes, and procedures
Support EU Surgical Operating Unit entities from a Quality Oversight perspective
Provide proactive support for QMS processes, audits, and certifications
Provide reactive support for production quality issue resolution, PHO, and FCA support
Partner with and influence internal and external stakeholders to drive change and execute compliance programs
Communicate business-related issues or opportunities to the next management level
Lead, coordinate, and/or prepare internal and external audits in accordance with regulatory standards
Perform trend analyses and report compliance observations to identify improvement areas
Investigate and resolve compliance problems, questions, or complaints from company units, customers, and regulatory authorities
Maintain knowledge of applicable Quality, FDA medical device directives/regulations, HIPPA, and ISO requirements through policy and procedure updates
Act as liaison with appropriate policy experts
Produce clear written documentation and use computer systems effectively

Requirements

What you’ll need

Bachelor’s Degree
Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
Demonstrated knowledge of quality system elements and regulatory requirements, including FDA, GMP, QSR, ISO 13485, and MDSAP, for finished medical devices
Ability to implement and communicate quality and regulatory requirements in a government-regulated healthcare industry
Knowledge of Core QMS, Design Control, and Manufacturing processes/requirements
Effective usage of data analysis tools, analytical and research skills, and problem-solving techniques
Keen attention to detail and ability to follow an audit trail to identify risks, non-conformances, and true root cause
Outstanding written, oral communication, and presentation skills
Sound judgment, decision-making ability, independent work capability, and demonstrated leadership skills
Ability to manage and execute multiple critical projects simultaneously, manage multiple priorities, and escalate issues
Unrestricted U.S. work authorization at the time of hire and for the duration of employment; sponsorship is not offered for roles below Principal level
For Baccalaureate degrees earned outside of the United States, a degree satisfying 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
Approximately 25% domestic and international travel
Nice to have: 1 or more years of relevant experience in a Design & Development and/or Manufacturing setting
Nice to have: Experience supporting and/or participating in regulatory inspections and audits

Benefits

Comp & perks

Competitive Salary and flexible Benefits Package
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
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
Temporary employees are eligible for paid sick time, as required under applicable state law
Temporary employees are eligible for the Employee Stock Purchase Plan