J&J Family of Companies Strategic Collaboration Change Control Process Specialist in Le Locle, Switzerland
The Johnson & Johnson Medical Devices Companies (JJMD) is recruiting for a Strategic Collaboration Change Control Process Specialist, located in any JJMD site, including the following: Warsaw, IN; Raynham, MA; West Chester, PA; Cincinnati, OH; Somerville, NJ; Zuchwil, Switzerland; LeLocle, Switzerland; Leeds, England; and Cork, Ireland.
The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.
You, the Specialist will play an important role in administering the change control processes between J&J Medical Device (JJMD) companies (currently within the Ethicon Endo Surgery, DePuy, and Synthes Quality Management Systems) and our Strategic Collaborator(s) to ensure compliance to the regulations and the Quality Agreement requirements.
• Maintain change control processes related to JJMD change control oversight of Strategic Collaborator’s changes, including:
• Change control procedures
• Approval matrices
• Product Lifecycle Management (PLM) system configurations
• Administer process for Strategic Collaborator’s restricted access in JJMD PLM systems
• Coordinate any assessment and reporting activities relating to Strategic Collaborator’s change control process
• Facilitate coordination of changes between JJMD and Strategic Collaborator
• Collect, analyze, and compile Strategic Collaborator-related change control metrics (cycle time, oversight checker failures, etc.)
• Lead and identify change control process improvements in partnership with Strategic Collaborator
• Support future projects to expand the Strategic Collaborator model in JJMD
• Support both internal and external audits, as well as quality events, relating to Strategic Collaborator change control processes
• Ensure all activities are in compliance with the documented quality system and current regulatory requirements
• A minimum of a University/Bachelor’s Degree (or equivalent 4-year degree) plus a minimum of six (6) years of business experience, including a minimum of one (1) year with electronic change control in regulated industry OR an Associate’s Degree (or equivalent 2-year degree) plus a minimum of eight (8) years of business experience, including a minimum of four (4) years with electronic change control experience in regulated industry OR a minimum of ten (10) years of business experience, including a minimum of five (5) years with electronic change control experience in regulated industry.
• The ability to lead projects to identify root cause of problematic situations, define solutions, and drive resolutions.
• Proficiency in Microsoft Outlook, Word, Excel, and PowerPoint, including extensive data analysis, macros, V-Lookups, graphing in Excel.
• Proficient in change control processes and Product Lifecycle Management (PLM) systems.
• Strict attention to detail with the ability to work in an open office environment and remotely with virtual teams.
• The ability to negotiate competing priorities with key stakeholders, to organize, prioritize, and handle multiple projects simultaneously and the ability to work independently and prioritize with little supervision.
• Strong written and oral communication and interpersonal skills.
• Able to accommodate occasional extended working hours (within local legal requirements).
• This position may require up to 10% domestic and international travel.
• Experience working in the medical device or pharmaceutical industry.
• Experience with Agile e6, ADAPTIV (Enovia platform), and/or Windchill PLM applications highly desired.
• Excellent knowledge of English language (C1 or native speaker) - basic understanding of German, French, and/or Spanish highly desired.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Europe/Middle East/Africa-Switzerland-Neuchâtel-Le Locle, Europe/Middle East/Africa-United Kingdom-England-Leeds, North America-United States-New Jersey-Somerville, North America-United States-Ohio-Cincinnati, North America-United States-Pennsylvania-West Chester, North America-United States-Massachusetts-Raynham, Europe/Middle East/Africa-Ireland-Cork-Cork, Europe/Middle East/Africa-Switzerland-Solothurn-Zuchwil
Medical Device Business Services, Inc (6029)