Senior Quality Systems Analyst

🔥 0 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

Founded 1886

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🧬 Biotechnology

Healthcare Insurance • Pharmaceuticals • Biotechnology

Johnson & Johnson is a multinational corporation focused on innovating across multiple sectors of healthcare and medicine. With a commitment to redefining healthcare, the company merges science and technology to address complex diseases through its divisions in innovative medicine and medical technology. Its areas of focus include oncology, immunology, neuroscience, and specialty ophthalmology, as well as interventional solutions and orthopaedics. J&J is dedicated to advancing global health equity and environmental sustainability while fostering innovation, diversity, and inclusion in the workplace. The company strives to provide solutions that connect health and care for providers, patients, and communities worldwide.

📋 Description

• 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. • 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.

🎯 Requirements

• 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 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