Johnson & Johnson Careers
Quality System Analyst
Requisition ID: 1805703868W
- Drive the execution of Quality Systems (QS) at site level, including Nonconformances (NC), Corrective and Preventive Action (CAPA), Internal Audit (IA) Observations, Site Complaint Manufacturing Investigations, Product Quality Escalation, Quality Progress Review (QPR) and Quality System Management Review (QSMR) to ensure systems meet all business and regulatory requirements.
- Manage the performance and communication of QS metrics at site level. Support site readiness in the deployment of these QS initiative.
- Support compliance and continuous improvement of the Quality System.
- Support document control area where needed.
Position duties and responsibilities
- Ensures consistent and correct execution of QS procedures at the site to maintain the quality and compliance of processes and records for NC, CAPA, IA Observations, Product Quality Escalation,
Site Complaint Manufacturing Investigations, QPR and QSMR. This includes:
- Review site CAPAs, NCs, IA Observations, Site Complaint Manufacturing Investigations, QPR and
- Provide guidance on requirements
- Assist with the development and documentation of problem statements, bounding, containment, risk assessments, investigation, and action plan determination (corrections, corrective actions, preventive actions, and effectiveness monitoring)
- Ensure effective completion of activities
- Ensure timely escalation of product quality and compliance issues to the proper source (NC,
CAPA, Product Quality Escalation)
- Execute CAPAs, NCs, and IA Observations related to site-specific QS
- Develops competency of resources at the site that execute CAPA, NC, IA Observations, Product
Quality Escalation, Site Complaint Manufacturing Investigations, QPR and QSMR by providing
training and guidance on the execution and documentation of these p
- Drives timely and compliant execution of site NCs, CAPAs, IA Observations, Product Quality
Escalation, Site Complaint Manufacturing Investigations, QPR and QSMR by driving cross-
collaboration across functions, monitoring progress, and elevating issues in a timely manner for
- Supports on site the timely collection, escalation and reporting of Quality System metrics to
management. This includes:
- Provide management tracking reports for NC, CAPA, IA Observation, and Site Manufacturing
- Submit NC, CAPA, IA Observation, and Site Manufacturing Complaint Investigation metrics for
QPR and QSMR
- Performs administrative activities for NCs, CAPAs, IA Observations, Product Quality Escalation, Site
Complaint Manufacturing Investigations, QPR and QSMR. This includes:
- Coordinate activities related to CAPA Review Board (CRB) and facilitate forums for review of
progress of NCs, IA Observations and Site Complaint Manufacturing Investigations (i.e. agenda, scheduling, documentation of minutes, tracking of activities)
- Support on-site QPR and QSMR, including coordination, preparation, execution, and tracking of
- Support Product Quality Escalations for nonconformances or issues originating at the site, including the initiation, escalation, coordination, tracking, and closure of activities
- Support the initiation of CAPAs
- Serve as site administrator for EtQ and Cognos
- Supports the maintenance of original documentation for site NC, CAPA, IA Observations, Product Quality Escalation, Site Complaint Manufacturing Investigations, QPR and QSMR as quality records, and maintains meeting mintues for official review boards, where required.
- Identifies site needs to meet and improve system performance of NC, CAPA, IA Observations, Product Quality Escalation, Site Complaint Manufacturing Investigations, QPR and QSMR at the site level, and escalates to appropriate representative and management in a timely manner
- Supports the deployment (design, implementation, and post-monitoring) of CAPA, IA Observations, Product Quality Escalation, Site Complaint Manufacturing Investigation, QPR and QSMR process initiatives impacting the site that promote the continuous improvement of the QS and ensure continuity of the application of globally shared processes and systems at site level
- Supports compliance activities by participating in audit readiness; assisting in Internal and External audits; serving as Subject Matter Expert for NC, CAPA, IA Observations, Product Quality Escalation, Site Complaint Manufacturing Investigations, Document Control, QPR and QSMR process during audits; supporting the investigation, response, and remediation of site-specific QS audit
- Manage on site Document Control (as required), including management of change documentation,
on-site administration of the change control system, and archival of documents on site
- University/Bachelor’s Degree or Equivalent
Degree in Engineering is preferred, or associated relevant Scientific / Technical / Quality discipline
Two (2) years related experience in Medical Device or Pharmaceutical environment, or equivalent
combination of education and experience is required
Experience in working in a manufacturing / operations environment is preferred
Knowledge of ISO and QSR regulations is required
Experience in Quality Auditing and notified body inspections is preferred Experience with root cause investigation, change management, risk management and technical
writing is required
- Experience in Quality Systems process development, support, integration or enhancement is
- Experience in Project Management is preferred
- A Certification in process excellence is preferred
- Advanced use of computer and software applications is required
- Experience with training or coaching others is required
- Strong communication, influencing and leadership skills: ability to communicate at all levels of the organization, and to interact with and influence cross-functional and cross-business teams to drive
results is required
- Strong business acumen, interpersonal skills relating to teams with diverse cultures and business
practices is required.
- Strong verbal and written communications skills for multi-level stakeholders
- Strategic and tactical execution abilities, including strong organization skills is required.
- Ability to take initiative regarding innovative approaches to problem solving in a fast-paced, changing business environment is required.
- Ability to apply principles of logical or scientific thinking, root cause and statistical analysis.
- Ability to analyze, graph, and present data in a way that facilitates and drives decision making.
- Strong verbal and written Presentation Skills
German: Business fluent
English: Business fluent
ETHICON Women's Health & Urology Sarl (8566)