search
Home > Cincinnati jobs > Cincinnati computer/technical

Posted: Wednesday, October 4, 2017 3:37 AM

Description

Johnson & Johnson Medical Devices, a member of Johnson & Johnson family of companies, is currently recruiting for a Custom Package and Label Design Review Leads located in Cincinnati, OH or Somerville, NJ with a minimum of 10% travel.

Johnson & Johnson Medical Devices is currently $20 billion in World Wide sales. The business is expected to experience solid growth over the next 5 to 7 years. Johnson & Johnson Medical Devices contains key surgical platforms such as Wound Closure, Orthopedics, Open and Minimally Invasive Stapling, Energy, Biosurgery, Aesthetics, ENT, and Cardiovascular surgical products.

The Custom Package and Label Design Review Lead is responsible for:

• Leading the Repack and Relabel Council for the business(es) assigned.
• Administer process for Repack & Relabel Council intake, review, facilitation, and final disposition of affiliate-based activity requests
• Collaborate with countries to educate and insuring request forms are complete and adequate for council review.
• Maintaining records of intake, in process and dispositioned requests
• Coordinate communications with council members, requestors and ad hoc reviewers including meeting schedules, status, pre-work, agendas and minutes.
• Develop and maintain analytics and metrics of the council effort.
• Determine and maintain prioritization process
• Prepare, communicate and distribute status and metrics as appropriate.
• Ensure compliance to procedures and standards.
• Provide input, initiate and/or lead improvements to process.
• Maintain local procedures as required.
• Provide training and audit support for process as required.
• Provide leadership and collaborate with stakeholders to plan approaches for compliance, review and disposition of legacy processes.
• Escalation support as needed.
• Maintain Council membership participation assignments with Packaging, Labeling, Franchise Product Management, Commercial, Regulatory, Medical and Quality
• POLICIES: Know & follow applicable Enterprise and Medical Device policies
• TRAINING: Complete training in area of responsibility & assure that direct reports are trained within allowed time-period. Training is required for changes in existing policies & procedures, for new assignments & for implementation of new policies & procedures. Complete required periodic re-training & assure that required periodic re-training takes place for direct reports in areas such as safety & environmental.
• SAFETY: Set standards for safe behavior. Recognize & reward safe behavior in others. Ensure direct reports employ safe practices. Enforce safety policies & procedures. Evaluate staff member’s safety performance & insure that safety is a part of each direct report’s GPMS.
• Ensure compliance to Quality System process for providing Franchise design.
• Provide input, initiate and/or lead improvements to process and approach for risk mitigation.
• Provide training and audit support for process.
• Administer process for Repack & Relabel Council intake, review, facilitation, and final disposition of affiliate-based activity requests.
• Provide leadership and collaborate with stakeholders to plan approaches for compliance, review and disposition of legacy processes.
• Provide analytics and establish and report metrics of the council effort.
• Partner with CLS Repack and Relabel Compliance leadership and/or Regional supply chain leads for demand and resource planning.

Qualifications
• A B.A./B.S. in Engineering or technical field is required.
• A minimum of 3+ years of work experience with demonstrated leadership within an individual contributor role is required.
• ISO 13485, ISO 15223, ISO14971, ISO 11607 knowledge and experience is strongly preferred.
• Experience in Quality Control, Compliance or Regulatory is required.
• Project Management Mastery or FPX certification is preferred.
• Process Excellence Green Belt in Six Sigma or Lean is preferred.
• Certified Quality Engineer or Auditor is preferred.

Primary Location
United States-Ohio-Cincinnati
Other Locations
North America-United States-New Jersey-Somerville
Organization
MD&D Global Services LLC (6209)
Job Function
Quality Control
Requisition ID
4845170925

Click here for more info: https://jnjc.taleo.net/careersection/2/jobdetail.ftl?job=4845170925&lang=en


• Location: Cincinnati

• Post ID: 50366717 cincinnati
cincinnati.backpage.com is an interactive computer service that enables access by multiple users and should not be treated as the publisher or speaker of any information provided by another information content provider. © 2017 backpage.com