Senior Quality Systems Analyst

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Johnson & Johnson is currently recruiting for Senior Quality Systems AnalystUS 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 bachelors 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 preferred.

Required skills and certifications:

• 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.

Job location: United States: Domestic travel up to 25% may be required based on business needs.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via . internal employees contact AskGS to be directed to your accommodation resource.

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Senior IC