Senior Quality Systems Analyst
Location
Massachusetts
Posted
4 days ago
Salary
$94K - $151.8K / year
Seniority
Senior
Job Description
Senior Quality Systems Analyst
Johnson & Johnson
• 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.
Job 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
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