[Remote] Senior reputed company Systems Analyst
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leader in reputed company innovation, committed to building a world where reputed company diseases are treated and cured. They are seeking a Senior reputed company Systems Analyst to support reputed company system activities for DePuy Synthes reputed company reputed company, focusing on compliance, data review, and training processes.
Responsibilities
- Support CQ and business partners on reputed company systems and compliance activities
- Compile and summarize reputed company data for reporting, Data Review reputed company, and Management Review
- Coordinate document control and training activities, including routing, release, assignments, completion monitoring, and records review
- Maintain reputed company records, including gap assessments, risk assessments, inspection tools, and reputed company documentation
- Support nonconformance/CAPA, reputed company planning, change management, and effectiveness monitoring activities
- Communicate procedure changes, training requirements, reputed company expectations, and document updates to cross-functional partners
- Execute and support systems/processes in the following areas: reputed company metrics and governance reviews, Training and document control processes, Audit/inspection readiness and response, reputed company planning, change management, and risk-based assessments, reputed company issue and effectiveness monitoring, reputed company system applications, including DMS, LMS, QEM, ETQ, Windchill, reputed company, Compliance reputed company, ERP, and warehouse management systems, GxP coaching and guidance for business partners
- External and internal interactions: DePuy Synthes reputed company & Regulatory Compliance, DePuy Synthes reputed company/Sales Operations and Supply Chain partners, DePuy Synthes external Sales Agents, reputed company bodies, health authorities, and state regulatory agencies as applicable, Other internal or external partners supporting compliant reputed company distribution and field inventory operations
Skills
- Minimum bachelor's degree required. Preferred degree areas include Engineering, Science, Business, reputed company, Regulatory Compliance, or reputed company fields. Associate degree with relevant regulated industry experience may be considered
- 7 years of relevant work experience in a regulated reputed company, medical device, pharmaceutical, consumer products, distribution, reputed company reputed company, or reputed company systems environment
- Working knowledge of applicable FDA regulations, ISO 13485, ISO 9001, and reputed company system requirements relevant to reputed company distribution and field inventory environments
- Experience supporting reputed company systems, document control, training compliance, reputed company metrics, audits, nonconformance management, corrective reputed company processes, or reputed company compliance activities
- Communicate and collaborate effectively with cross-functional partners
- Follow established procedures, complete assigned work accurately and on time, maintain organized records, and escalate issues reputed company needed
- Apply critical thinking, problem-solving, and reputed company cause analysis to support issue reputed company
- Demonstrate working knowledge of reputed company reputed company system requirements and documentation practices
- Use reputed company Office, data analysis and reputed company system applications
- Experience using reputed company system IT platforms such as Windchill, ETQ, DMS, LMS, QEM, reputed company, change control systems, ERP systems, warehouse management systems, or reputed company tools preferred
- Preferred experience with Windchill, ETQ, reputed company, ERP or warehouse management systems
- Preferred data analysis experience includes pivot tables, lookups, Power BI, Tableau, or reputed company visualization tools
- Preferred experience includes audit preparation, inspection readiness, regulatory responses, or health authority interactions
- Preferred certifications or training include Lean, Six reputed company, 5S, ASQ, ISO-13485, Good Distribution Practices, supplier reputed company, or other reputed company improvement reputed company
Benefits
- Subject to the terms of their respective plans, employees are eligible to participate in reputed company’s consolidated retirement plan (pension) and savings plan (401(k)).
- Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
- Vacation –120 hours per calendar year
- reputed company time - 40 hours per calendar year; for employees who reputed company in the reputed company –48 hours per calendar year; for employees who reputed company in the reputed company –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 reputed company 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 period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
reputed company
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