Quality Systems Analyst II

vor 4 Wochen

Oberdorf BL, Basel-Land, Schweiz Johnson & Johnson AG Vollzeit

Are you good at organizing knowledge and connecting connections? Do you enjoy keeping things in order and making sure everything makes logical sense? Are you the type of person who is willing to find solutions to complex problems and keeps a cool head when the requests pile up? Would you like to use these skills to improve the lives of cancer patients at the forefront of medical research? If the answer to these questions is yes, we are looking for you

At Johnson & Johnson we believe health is everything. Our strength in health innovation enables us to create a world where complex diseases are prevented, treated and cured, and treatments are smarter, less invasive and solutions are personal. Our expertise in innovative medicine and MedTech puts us in a unique position to inject innovative solutions across the entire spectrum of health to achieve the breakthroughs of tomorrow. We combine science, technology and determination to profoundly improve the health of humanity. Find out more at

In Johnson & Johnson, we are looking for a Quality Systems Analyst II (m/f/d) for the location Oberdorf (Basel Land), Switzerland .

What you will do:

The Oberdorf Quality Systems Team is responsible for the compliance and continuous improvement of the site's Quality System (QS). In this role, you will work in a collaborative environment with various stakeholders and get hands-on experience with internal and external audits. The Quality Systems Analyst II will drive the execution of the QS at the site level, including Nonconformances (NC), Corrective and Preventive Action (CAPA), Internal Audit (IA) Observations, Product Quality Escalation, Site Complaint Manufacturing Investigations, Quality Progress Review (QPR), Quality System Management Review (QSMR), and Records Management to ensure the QS meets all business and regulatory requirements. You will also manage the performance and communication of Oberdorf QS metrics, as well as support site readiness in the deployment of QS initiatives. In addition, you will:

  • Ensure 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, and Records Management.
  • Review site CAPAs, NCs, IA Observations, Site Complaint Manufacturing Investigations, QPR and QSMR documentation
  • 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)
  • Identify site needs to meet and improve performance of these processes.
  • Coordinate, prepare, facilitate, execute, and track of activities of the Quality Progress Review (QPR) and Quality System Management Review (QSMR).
  • Have oversight and support the tracking of QS metrics at site level. Communicate status and issues to stakeholders and management, as needed.
  • Support site Document Control and Records Information Management activities.
  • Participate in audit readiness activities; assist with the preparation and execution of Internal and External Audits; may serve as a Subject Matter Expert (SME) for NC, CAPA, IA Observations, QPR, QSMR, and Records Management
  • Provide guidance on requirements and develop the competency of resources that execute the aforementioned QS processes.
Qualifications

We would love to hear from you if you have the following essential requirements:

  • Two (2) years related experience in Medical Device or Pharmaceutical environment, or equivalent combination of education and experience
  • Experience in technical writing, such as root cause investigations of NCs, CAPAs, and Observations, as well as change management and risk management
  • Knowledge of ISO standards and Quality System regulations
  • Advanced use of computer and software applications (e.g. Microsoft PowerPoint, Word, Excel, SharePoint, and Teams)
  • Detail-oriented and high level of accuracy
  • Pro-active approach to execution of deliverables and managing stakeholders
  • Time-oriented (i.e. able to recognize and adhere to strict timelines)
  • Strong communication and interpersonal skills (collaboration with multiple stakeholders is required)
  • Ability to follow-up with management-level stakeholders, and challenge, as necessary to ensure compliance to procedural requirements
  • Experience in training/coaching others
  • A high level of German-proficiency and intermediate English-proficiency is required for the role (successful candidate must be able to facilitate meetings and write documentation in both languages)
  • This is a temporal contract for 10 months .

We would prefer if you also bring:

  • Experience in Quality and notified body inspections is highly advantageous
  • Experience in working in a manufacturing/operations environment
  • Experience in Quality Systems process development and improvement
  • Experience facilitating or supporting Management Reviews or Quality Metric Reviews
  • Project management experience
  • A certification in process excellence

When you join Johnson & Johnson , you'll find limitless opportunities to shape your path and amplify your impact inside and outside our walls. And with our commitment to being the world's healthiest workforce, you can strengthen both your body and your mind. When you work at Johnson & Johnson , you touch over a billion lives around the world every day. And when you use your talents for our shared goal, there are no limits to the lasting impact we can achieve together. And that changes everything.

Diversity, Equity and Inclusion at Johnson & Johnson means "YOU Belong"

For more than 130 years, diversity, equity and inclusion have been part of our cultural fabric at Johnson & Johnson and woven into the way we do business every day. Our commitment to respecting the dignity and diversity of all is anchored in our Credo. We know that the success of our company depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values diverse perspectives and life experiences.

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