"Caring for the world… one person at a time” inspires and unites the people of Johnson & Johnson. 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. Our broad array of inspired, innovative and high-quality offerings help advance the health and wellbeing of people around the world.
As a key contributor within our Quality Operations Organization, you will ensure site readiness in the deployment of QS initiatives, while overseeing and managing the execution of Quality Systems (QS) at site level, including: Non-conformances (NC), Corrective and Preventive Action (CAPA), Internal Audit (IA) Observations, Site Complaint Manufacturing Investigations, Product Quality Escalation, Quality Progress Review (QPR), Quality System Management Review (QSMR), and other assigned QS activities to ensure systems are effective and in compliance.
You will manage the performance and communication of QS metrics at site level and support compliance and document control areas, and continuous improvement of the Quality System.
Responsibilities are for a site that is complex or has a demanding compliance profile.
- Responsible for the consistent and correct execution of QS procedures at the site to ensure the quality and compliance of processes and records for NC, CAPA, IA Observations, Site Complaint Manufacturing Investigations, Product Quality Escalation, QPR and QSMR
- Develop competency of resources at the site that execute NC, CAPA, IA Observations, Site Complaint Manufacturing Investigations, Product Quality Escalation, QPR and QSMR, by providing training and guidance on the execution and documentation of these processes
- Responsible for the timely and compliant execution of site NCs, CAPA, IA Observations, Site Complaint Manufacturing Investigations, Product Quality Escalation, QPR and QSMR, by championing cross-collaboration across functions, sites, and operating companies; identifying barriers for the progress; and elevating issues for resolution
- Manage on-site QPR and QSMR, including coordination, preparation, execution, and tracking of activities,
- Manage Product Quality Escalations for Non-conformances or issues originating at the site, including the initiation, escalation, coordination, tracking, and closure of activities
- Manage on site the timely collection, escalation and reporting of all Quality System metrics to management
- Maintain original documentation for site NC, CAPA, IA Observations, Site Complaint Manufacturing Investigations, Product Quality Escalation, QPR and QSMR as quality records
- Identify site needs to meet and improve system performance of NC, CAPA, IA Observation, Site Complaint Manufacturing Investigation, Product Quality Escalation, QPR and QSMR at the site level, and escalates to appropriate representative and management in a timely manner
- Collaborate with Franchise Quality in the deployment (design, implementation, and post-monitoring) of QS 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
- Support compliance activities by participating in audit readiness; assists in Internal and External audits; serves as Subject Matter Expert for NC, CAPA, IA Observation, Site Complaint Manufacturing Investigation, Product Quality Escalation, Document Control, QPR and QSMR processes during audits; manages the investigation, response, and remediation of site-specific QS audit observations
- Oversee 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, alternatively associated relevant Scientific / Technical / Quality discipline
- Minimum of 6 years related experience in Medical Device or Pharmaceutical environment, or equivalent combination of education and experience is required
- Fluency in German and English
- 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 preferred
- Experience in Project Management is preferred, a Certification in process excellence is preferred
- Experience with training or coaching others is required. Direct supervision experience is preferred
- Strong verbal and written 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
- Ability to analyze, graph, and present data in a way that facilitates and drives decision making
- Strong business acumen, strategic and tactical execution abilities, including strong organization skills are 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
If you feel attracted by this challenge and want to be part of a successful and growing organization, then please send us your online application.
Please click on DePuy Synthes and Johnson & Johnson if you want to learn more about our business and check our new career channel on YouTube www.youtube.com/user/CareersAtJNJto understand our working culture!
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 Tuttlingen (7131)