Associate Director, Worldwide Customer Quality
Location: Somerville New Jersey
Description: Ethicon Inc. is employing Associate Director, Worldwide Customer Quality right now, this job will be placed in New Jersey. Further informations about this job opportunity kindly see the descriptions. -
0683120730
Description
Ethicon, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Worldwide Customer Quality, located in Somerville, NJ.
Ethicon, Inc., a Johnson & Johnson company, is a trusted world-wide leader in surgical care. For over a century, Ethicon has continuously introduced innovations in wound closure, general surgery, wound management, women's health and urology and aesthetic medicine that fulfill the company's vision: Restoration of Body and of Life.
The Associate Director, Worldwide Customer Quality will assure compliance with all J&J Corporate directives including Complaint Vigilance. Reduce regulatory exposure through reduction in late MDR/MDV submissions. Reduce regulatory exposure through increase efficacy in management of product complaints by improvement in multiple complaint process metrics. Manage continuous improvement of Complaint Management process using Best Practice, World Class, PE approaches. Maintain and develop effective relationships with all stakeholders, including business unit QA/RA heads. Assure effective staff development, adequate resources and effective self assessment process. Manage all respects of the Product Complaint Process. Identify key customer issues related to product performance. Communicate said issues to management/ key stakeholders and be an advocate for associated corrective action. Provide periodic reports/ presentations of complaints and provide metrics to support various scorecards/ dashboards. Interface with regulatory agencies and ETHICON Affiliates on complaint-related issues. Support internal and external audits. Identify and implement opportunities for improving the process.
Qualifications
A minimum of a Bachelor's degree is required, preferably in a Scientific, Technical, Nursing and/or Engineering discipline. A minimum of 7 years experience working in a regulated healthcare industry (medical device & diagnostic or pharmaceuticals) is required. A minimum of 3 years supervisory experience is required. A technical background in systems, software programs and/or research (Complaint Handling Systems or other tracking systems/software, etc.) is strongly preferred. Clinical or Clinician experience is highly desired. Candidate must be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Operations, Purchasing, Marketing and Medical Affairs. Knowledge of quality systems regulations is required. Knowledge of statistical applications and auditing practices is an asset (FDA, ISO, etc.). Regulatory Reporting experience is required, specific understanding of FDA MDR reporting of Medical Device Vigilance is strongly preferred. General competency in QSR/ISO knowledge is an asset. Ability to communicate effectively with all levels of management and functions is required. This postion is based in Somerville, NJ and my require up to 10% travel.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location
North America-United States-New Jersey-Somerville
Organization
Ethicon Inc. (6045)
Relocation Eligible
No
Job Function
Regulatory Compliance
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This job starts available on: Wed, 08 Aug 2012 18:13:41 GMT