Johnson & Johnson Karrieren
Quality System Analyst
Requisition ID: 1805703868W
"Caring for the world… one person at a time” … inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo
DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we created one organization that will be agile and better equipped in today’s evolving health care environment. Our broad array of inspired, innovative and high-quality offerings help advance the health and wellbeing of people around the world.
- 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.
- 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 QSMR documentation
- 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
- 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 resolution
- 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 Complaint Investigations
- 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 activities
- 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)