Quality Process Lead

Johnson & Johnson

Quality Process Lead at DePuy Synthes responsible for managing Stop Shipment cases and ensuring compliance. Collaborating with stakeholders and leading communication efforts across the organization.

Posted 7/7/2026full-timeRaynham • Florida, Massachusetts, Pennsylvania • 🇺🇸 United StatesSenior💰 $65,000 - $104,650 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in quality systems and compliance within the healthcare and medical device sectors, with a strong focus on process improvements and stakeholder communication. Proficient in ERP systems and Microsoft Office tools, ensuring effective execution of quality-related tasks and investigations.

Highest-signal resume keywords

Quality Systems GuidanceERP Systems ExperienceISO 13485 KnowledgeFDA Standards FamiliarityProcess Improvement Expertise

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality SystemsProcess ImprovementProduct TraceabilityComplaint HandlingNon-Conformance Management

Soft Skills

Cross-Functional CollaborationStakeholder CommunicationResponsibility

Tools & Technologies

Microsoft OfficeOffice 365OutlookExcelPowerPointVisio

Industry Keywords

HealthcareMedical DeviceISO StandardsFDA RegulationsInternational Work Environment

Tech Stack

Tools & technologies

ERP

About the role

Key responsibilities & impact

Responsible for the execution of Stop Shipment Cases
Coordinating, leading communication between stakeholders, LOCs, and management
Work with ERPs and provide ERP support and guidance
Provide product traceability escalations and Field Actions
Changing, creating, and maintaining critical batch information (e.g. Expiry Date)
Analyse, define, and revise procedures, work instructions and documentation as well as implement process opportunities
Provide quality systems guidance and support the Non-Conformance, Complaint Handling
Work with stakeholders and provide support for investigations related to quality issues
Serving as Subject Matter Expert during audits

Requirements

What you’ll need

High School diploma or equivalent required
2 years of related experience in a Quality environment
Strong proficiency with Microsoft Office tools, including Outlook, Excel, PowerPoint, Visio, and Office 365
Worked with ERP systems
Worked in a diverse, international work environment
Ability to work cross functional and with diverse teams
High degree of responsibility
Familiar with ISO and FDA standards for medical products (ISO 13485 and 21CFR820)
Knowledge in Process Improvements
Worked in a healthcare/medical device environment

Benefits

Comp & perks

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