Analyst Quality Systems (m/f/d) (9 Months Contract)

Johnson & Johnson is currently looking for an Analyst Quality Systems (m / f / d) at the Oberdorf (Basel Land) site, Switzerland.

At Johnson & Johnson, we believe that health is everything. Our strength in healthcare 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 deliver tomorrow's breakthroughs.

We combine science, technology and determination to profoundly improve the health of humanity. Find out more at https : / / www.

jnj.com / 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.

Welche Auswirkungen wirst Du auch haben :

• 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. 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 9 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 have limitless opportunities to shape your path and amplify your impact inside and outside of our company.

And with our commitment to being the healthiest workforce in the world, you can strengthen your body and mind. When you work at Johnson & Johnson, you can touch over a billion lives around the world every day.

And when you apply your talent to our shared purpose, there are endless lasting impacts we can make together. And that changes everything.

Diversity, Equity & Inclusion at Johnson & Johnson means "You Belong"! For more than 130 years, Diversity, Equity & Inclusion (DEI) has been part of Johnson & Johnson's culture and integral to how we do business every day.

DEI values are rooted in our Credo and drive our pursuit of a healthier and more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve healthcare's most pressing challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve.

That's why we foster a culture of inclusion and belonging, where all perspectives, skills and experiences are valued and our employees can reach their potential.

At Johnson & Johnson, we all belong.