Senior Quality Systems Analyst

Johnson & Johnson

Senior Quality Systems Analyst executing quality system activities for US DePuy Synthes. Responsible for supporting quality system data review, metrics reporting, and compliance activities.

Posted 7/16/2026full-timeRemote • Massachusetts • 🇺🇸 United StatesSenior💰 $94,000 - $151,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in quality systems, compliance activities, and document control processes within regulated environments. Proficient in data analysis, quality metrics, and effective communication with cross-functional partners to ensure adherence to quality standards.

Highest-signal resume keywords

Quality Systems ManagementRegulatory Compliance KnowledgeDocument Control CoordinationData Analysis ProficiencyGxP Coaching

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality MetricsNonconformance ManagementCorrective Action ProcessesRoot Cause AnalysisQuality System RequirementsData AnalysisAudit PreparationInspection ReadinessChange ManagementRisk Assessments

Soft Skills

Effective CommunicationCollaborationCritical ThinkingProblem-SolvingOrganizational Skills

Tools & Technologies

WindchillETQDMSLMSQEMSummitERP SystemsWarehouse Management SystemsMicrosoft OfficePower BI

Certifications & Qualifications

LeanSix Sigma5SASQISO-13485Good Distribution Practices

Industry Keywords

FDA RegulationsISO 13485ISO 9001HealthcareMedical DevicePharmaceuticalConsumer ProductsCommercial QualityQuality Systems EnvironmentField Inventory Operations

Tech Stack

Tools & technologies

ERPTableau

About the role

Key responsibilities & impact

Support CQ and business partners on quality systems and compliance activities.
Compile and summarize quality data for reporting, Data Review Board, and Management Review.
Coordinate document control and training activities, including routing, release, assignments, completion monitoring, and records review.
Maintain quality records, including gap assessments, risk assessments, inspection tools, and related documentation.
Support nonconformance/CAPA, quality planning, change management, and effectiveness monitoring activities.
Communicate procedure changes, training requirements, quality expectations, and document updates to cross-functional partners.
Execute and support systems/processes in quality metrics and governance reviews, training and document control processes, audit/inspection readiness and response, quality planning, change management, and risk-based assessments, quality issue and effectiveness monitoring, quality system applications, including DMS, LMS, QEM, ETQ, Windchill, Summit, Compliance Wire, ERP, and warehouse management systems.
Provide GxP coaching and guidance for business partners.
Facilitate external and internal interactions with partners such as DePuy Synthes Quality & Regulatory Compliance, DePuy Synthes Commercial/Sales Operations, Supply Chain partners, Sales Agents, Notified bodies, health authorities, and relevant internal or external partners supporting compliant commercial distribution and field inventory operations.

Requirements

What you’ll need

Minimum bachelor’s degree required. Preferred degree areas include Engineering, Science, Business, Quality, Regulatory Compliance, or related fields.
Experience: 7 years of relevant work experience in a regulated healthcare, medical device, pharmaceutical, consumer products, distribution, commercial quality, or quality systems environment.
Working knowledge of applicable FDA regulations, ISO 13485, ISO 9001, and quality system requirements relevant to commercial distribution and field inventory environments.
Experience supporting quality systems, document control, training compliance, quality metrics, audits, nonconformance management, corrective action processes, or related compliance activities.
Experience using quality system IT platforms such as Windchill, ETQ, DMS, LMS, QEM, Summit, change control systems, ERP systems, warehouse management systems, or related tools preferred.
Required skills include: Communicate and collaborate effectively with cross-functional partners.
Follow established procedures, complete assigned work accurately and on time, maintain organized records, and escalate issues when needed.
Apply critical thinking, problem-solving, and root cause analysis to support issue resolution.
Demonstrate working knowledge of standard quality system requirements and documentation practices.
Use Microsoft Office, data analysis and quality system applications.
Preferred experience with Windchill, ETQ, Summit, ERP or warehouse management systems.
Preferred data analysis experience includes pivot tables, lookups, Power BI, Tableau, or related visualization tools.
Preferred experience includes audit preparation, inspection readiness, regulatory responses, or health authority interactions.
Preferred certifications or training include Lean, Six Sigma, 5S, ASQ, ISO-13485, Good Distribution Practices, supplier quality, or other quality improvement methods.

Benefits

Comp & perks

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year