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Johnson & Johnson Karrieren

Quality Systems Coordinator

Bettlach, Schweiz
Quality Systems


Arbeitsplatzbeschreibung

Requisition ID: 1805703888W

"Caring for the world… one person at a time” … inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. 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. Building on the legacy and strengths of two great companies, we created one organization that will be agile and better equipped in today’s evolving health care environment. Our broad array of inspired, innovative and high-quality offerings help advance the health and wellbeing of people around the world.
 
 
For our Site in Bettlach we are looking for an
 
 Quality Systems Coordinator II
  
 

Overall responsibilities

 

Oversee manufacturing site Document Control and Change Control, including management of change documentation for the duration of changes, on-site administration of the change control system, and archival of documents on site to ensure all business and regulatory requirements are met. Support site readiness in the deployment of initiatives. Support compliance and continuous improvement of the Quality System.

 

Position duties and responsibilities

 

  • Ensures consistent and correct execution of change management procedures at the site to maintain the quality and compliance of the process and the records for document creation and changes. This includes:
  • Review site change request and change order documentations
  • Provide guidance on requirements
  • Assist with determination of risk assessments, actions and justifications
  • Assist with selection of assessment owners and approvers
  • Verify completion of action plans prior to release
  • Provide guidance on preparation for document archival
  • Execute NCs related to site-specific QS
  • Develops competency of resources at the site that create and change documents, by providing training and guidance on the execution and documentation of these changes. This includes:
  • Provide training on how to apply the procedure and use the system
  • Provide guidance on redlines and document changes during the process
  • Drives timely and compliant execution of document changes by driving crosscollaboration across functions, monitoring progress, and elevating issues in a timely manner for resolution, Performs administrative activities for document changes. This includes:
  • Release of change requests
  • Upload objective evidence and attachments to a change order
  • Release change orders
  • Oversees the control and maintenance of released documents
  • Control released hard copy document revisions
  • Identifies site needs to meet and improve system performance of document control at the site level, and escalates to appropriate representative and management in a timely manner, Supports the Document Control process initiatives impacting the site that promote the continuous improvement of the QS and ensure continuity of the application of processes and systems at site level
  • Supports compliance activities by participating in audit readiness; assisting in Internal and External audits; serving as Subject Matter Expert for Document and Change Control process during audits; supporting the investigation, response, and remediation of site-specific QS audit observations

 

 


Qualifikationen
  • Two (2) years 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
  • Knowledge of ISO and QSR regulations is required
  • Experience in Quality Auditing and notified body inspections is preferred
  • Experience with change management, risk management, technical writing, or Quality Systems processes preferred
  • A Certification in process excellence is preferred
  • Basic use of computer and software applications required, document management system preferred
  • Experience with training or coaching others is preferred
  • Interpersonal skills / characteristics:
  • Ability to communicate at different 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
  • Ability to take initiative in a fast-paced, changing business environment is required.

Primärer Standort
Schweiz-Solothurn-Bettlach-
Organisation
ETHICON Women's Health & Urology Sarl (8566)
Funktion
Quality Systems
Requisition ID
1805703888W