Senior Quality Systems Analyst

🔥 4 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $94k - $151.8k / year

⏰ Full Time

🟠 Senior

⚙️ Systems Engineer

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Johnson & Johnson

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🧬 Biotechnology

🧘 Wellness

Pharmaceuticals • Biotechnology • Wellness

<Johnson & Johnson> is a global healthcare company that researches, develops, manufactures and markets pharmaceuticals, medical devices and consumer health products. The company focuses on innovative medicines and therapies across oncology, immunology, neuroscience and cardiopulmonary areas, and develops MedTech solutions in cardiovascular, orthopaedics, surgery and vision. Johnson & Johnson also engages in health & wellness education, large-scale manufacturing, investor activities and global social-impact initiatives.

📋 Description

• 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

• 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

• 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