Senior Quality and Compliance Specialist

Johnson & Johnson

. Develop, execute, and oversee Quality and Compliance programs for the orthopedic last mile operations network within the United States .

Posted 9/18/2026full-timeRemote • Pennsylvania • United StatesSenior💰 $94,000 - $151,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality and Compliance programs within regulated healthcare and medical device environments, with a strong focus on FDA regulations, ISO standards, and quality system requirements. Proven ability to lead audits, manage nonconformances, and implement corrective action plans while collaborating effectively with cross-functional teams.

Highest-signal resume keywords

Quality Systems ManagementFDA Regulations CFR 820ISO 13485 ComplianceNonconformance ManagementAudit Preparation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality MetricsCorrective Action ProcessesDocument ControlData AnalysisTechnical Writing

Soft Skills

Critical ThinkingProblem-SolvingEffective CommunicationCollaboration

Tools & Technologies

WindchillETQERP SystemsWarehouse Management SystemsQuality System Applications

Certifications & Qualifications

LeanSix SigmaISO-13485Good Distribution Practices

Industry Keywords

Regulated HealthcareMedical DeviceCommercial QualityField InventoryQuality Improvement Methods

Tech Stack

Tools & technologies

ERP

About the role

Key responsibilities & impact

Develop, execute, and oversee Quality and Compliance programs for the orthopedic last mile operations network within the United States
Support internal and external orthopedic last mile Field Inventory operations, Loaner Sites, and Distribution Centers delivering field inventory and surgical loaner sets
Collaborate with Quality, Supply Chain, Delivery, Sales, and Commercial partners on distribution and commercial quality matters
Drive timely resolution of quality-related issues and support improvement opportunities aligned with business objectives and regulations
Define, implement, and validate quality requirements and systems
Serve as the single point of contact for assigned operations
Host and lead audits, inspections, investigations, and remediation activities
Ensure the Quality program maintains regulatory compliance
Provide quality support for existing and new distribution processes and go-to-market models
Develop, implement, and review standard operating procedures
Maintain relationships with orthopedic last mile operations and Franchise customers
Execute and improve inspection readiness, process changes, validation, calibration, preventive maintenance, and delivery service issue systems/processes
Investigate nonconformances and develop, implement, and monitor corrective action plans for effectiveness
Coach and mentor other functional areas on ISO and cGMP requirements

Requirements

What you’ll need

A minimum of a Bachelor’s or equivalent University degree is required
6–7 years of relevant work experience in a regulated healthcare, medical device, pharmaceutical, consumer products, distribution, commercial quality, or quality systems environment
Working knowledge of FDA regulations CFR 820, ISO 13485, ISO 9001, and quality system requirements relevant to medical devices, 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
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
Working knowledge of quality system requirements, good documentation practices, technical writing, Nonconformance, and CAPA
Proficiency with Microsoft Office, data analysis, and quality system applications
Preferred experience with Windchill, ETQ, Summit, ERP, or warehouse management systems
Preferred experience with audit preparation, inspection readiness, regulatory responses, or health authority interactions
Preferred certifications or training in Lean, Six Sigma, 5S, ASQ, ISO-13485, Good Distribution Practices, supplier quality, or other quality improvement methods

Benefits

Comp & perks

Retirement plan (pension)
Savings plan (401(k))
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; 48 hours for employees residing in Colorado; 56 hours for employees residing in Washington
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 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
Inclusive interview process and disability accommodations
Up to 25% domestic and international travel may be required