Senior Quality Systems Analyst

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Systems

Job Category:

Professional

All Job Posting Locations:

Raynham, Massachusetts, United States of America, Remote (US)

Job Description:

Johnson & Johnson is currently recruiting for Senior Quality Systems Analyst–US Last Mile! This position can be performed remotely within United States. Remote work may be considered on a case-by-case basis and if approved by the business.

Position Summary:

The Sr Quality Systems Analyst executes quality system activities supporting US DePuy Synthes Commercial Quality (CQ), distribution sites, regional functions, and Last Mile field inventory managers. The role is responsible for supporting quality system data review, metrics reporting, document management, training process execution, and compliance activities that help maintain an effective Quality Management System for commercial activities in the US

Key responsibilities:

• 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.
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Execute and support systems/processes in the following areas:

• 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

External and internal interactions:

• 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.  (i.e. Marketing)

Required Qualification and Core Competencies for the role:

• 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.

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 pref