Johnson & Johnson Careers
Quality Systems Analyst (m/f/d) (Maternity cover)
Requisition ID: 1905724924W
Johnson & Johnson is the world´s most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services. The values that guide our decision making are motivated by a culture of caring: Caring for the world, one person at a time… inspires and unites the people of Johnson & Johnson. The company is operating in the fields of pharmaceuticals, medical devices and consumer health care products in more than 250 companies around the world.
To support our production site in Umkirch we are currently looking for a Quality System Analyst (m/f/d)
This position is a maternity cover on a limited basis until September 2019.
The main activities of the Quality System Analyst is to ensure the consistent and correct execution of QS procedures at the site to maintain the quality and compliance of processes and records for NC (Non Conformities), CAPA (Corrective and Preventive Action), Internal Audit Observations, Product Quality Escalation, Site Complaint Manufacturing Investigations, QPR (Quality Process Reviews) and QSMR (Quality System Management Reviews).
This includes the following main tasks:
- Using basic statistical methods, quality tools and computer-generated reports to improve process capability.
- Participating in quality system improvement initiatives.
- Assist with the development and documentation of problem statements, bounding, containment, risk assessments, investigation and action plan determination
- Ensure timely escalation of product quality and compliance issues to the proper source (NC, CAPA, Product Quality Escalation)
- Develops competency of resources at the site that execute CAPA, NC, Audit Observation
- Supports on site the timely collection, escalation and reporting of Quality System metrics to management (QPR, QSMR) including coordination, preparation, execution and tracking of activities
- Supports compliance activities by participating in audit readiness, assisting in Internal and External audits, serving as Subject Matter Expert for NC, CAPA, OBS, Document Control, QPR and QSMR process during audits.
- Manage on site Document Control including management of change documentation, administration and archival of documents.
• University Degree, preferably in Engineering or related technical field.
• Relevant experience desirable
• This position will require relevant experience working in manufacturing/operations.
• Knowledge of ISO and QSR regulations is required
• Experience in root cause investigation, change and risk management is required
• Experience in technical writing is required
• Good technical understanding of manufacturing equipment and processes is required.
• Ability to perform "hands on" troubleshooting and problem solving
• Excellent communication skills with various internal stakeholders
• Proficieny in German and English is required
• Experience in Quality Auditing
• Experience in Quality Systems process development, support, integration or enhancement
• Experience in project management
This position is suited for young graduates with a technical or engineering background, who wish to focus on Quality Management.
The well-being and development of our employees are central aspects of our company creed. Individuals who would like to fully realize their potential as part of our international, innovation-driven corporate family and who aspire to have challenging work, will find that our company provides just the right conditions. We consider intensive initial training, further education that is tailored to our employees' work and excellent opportunities for development - both nationally and internationally - to be just as essential as a good work-life balance, attractive compensation and above-average employee benefits. One aspect that distinguishes our company is the large number of measures we have to support our trainees and promote career development in ways that are also compatible with family life.
Synthes Umkirch (7127)