Senior Quality Systems Analyst

Position Summary

The Sr Quality Systems Analyst supports U.S. DePuy Synthes Commercial Quality (CQ), distribution sites, regional functions, and Last Mile field inventory managers. The role ensures a robust Quality Management System for commercial activities in the U.S. by managing quality system data, metrics reporting, document control, training execution, and compliance activities.

• 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.

• 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
• GxP coaching and guidance for business partners

• DePuy Synthes Quality & Regulatory Compliance
• DePuy Synthes Commercial/Sales Operations and Supply Chain partners
• DePuy Synthes external Sales Agents
• Notified bodies, health authorities, and state regulatory agencies as applicable
• Other internal or external partners supporting compliant commercial distribution and field inventory operations (e.g., Marketing)

• Minimum bachelor’s degree required. Preferred degree areas include Engineering, Science, Business, Quality, Regulatory Compliance, or related fields.
• Associate degree with relevant regulated industry experience may be considered.
• 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.
• Communicate and collaborate effectively with cross‑functional partners; follow established procedures, complete assigned work accurately and on time, maintain organized records, and raise 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 PowerBI, Tableau, or related visualization tools.
• Preferred experience with 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.

Anticipated base pay range: $94,000.00 – $.

Benefits include: vacation, sick time, holiday pay, parental leave, bereavement leave, caregiver leave, volunteer leave, and military spouse time‑off. Additional benefits and details are available upon request.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, or other characteristics protected by federal, state or local law.

Johnson & Johnson actively seeks qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section
503 of the Rehabilitation Act. We are committed to providing an inclusive interview process and accommodations for applicants with disabilities.