Johnson & Johnson Careers
Senior QS Engineer
Requisition ID: 1905751947W
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.
For our production site, we are looking for a highly committed:
- Responsible for the consistent and correct execution of QS procedures 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, reporting and tracking Stop Shipments
- Execute NC, CAPA, IA Observations, Site Complaint Manufacturing Investigations, Product Quality Escalation, QPR and QSMR, reporting and tracking Stop Shipments by providing support and guidance to the site teams,
- Responsible for the timely and compliant execution of site NCs, CAPA, IA Observations, Site Complaint Manufacturing Investigations, Product Quality Escalation, QPR and QSMR, reporting and tracking Stop Shipment by championing cross-collaboration across functions, sites, and operating companies; identifying barriers for the progress; and elevating issues for resolution,
- Prepare QPR and QSMR and tracking of activities,
- Participates to Product Quality Escalations for nonconformances or issues originating at the site, including the initiation, escalation, coordination, tracking, and closure of activities
- Handles on site the timely collection, escalation and reporting of all Quality System metrics to management
- Maintains original documentation for site NC, CAPA, IA Observations, Site Complaint Manufacturing Investigations, Product Quality Escalation, QPR and QSMR as quality records, reporting and tracking Stop Shipment
- Identifies 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 local management in a timely manner,
- Collaborates 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,
- Supports 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
- Participates and maintains site Document Control (as required), including handle of change documentation, on-site administration of the change control system, and archival of documents on site
- Extended duties
- Other Quality Systems assignment, tasks, responsibilities, and projects as assigned
- University/Bachelor’s Degree or Equivalent
- Degree in Engineering is preferred, or associated relevant Scientific / Technical / Quality discipline
- 1-2 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
- Good knowledge of ISO and QSR regulations is required
- Some experience in Quality Auditing and notified body inspections is preferred
- Some experience with root cause investigation, change management, risk management and technical writing is required
- Some experience in Quality Systems process development, support, integration or enhancement is preferred
- Some experience in Project Management is preferred
- Good knowledge in use of computer and software applications is required
- Good experience with training or coaching others is required
- Strong communication: 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
- Strong organization skills 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
- French: fluent
- English: Business fluent
If you want to be a change agent in a challenging environment and shape the future quality organization, please send us your online application (CV, Motivation Letter, Working References etc.).
Medos International Sarl (7898)