Supervisor, Customer Quality


The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Supervisor, Customer Quality aligned to Advanced Sterilization Products (ASP), located in Irvine, CA.


ASP (Advanced Sterilization Products), a member of the Johnson & Johnson Family of Companies, is a leading designer and developer of innovative instrument sterilization, high-level disinfection and cleaning technologies. The company is dedicated to providing infection prevention solutions that create the safest possible environments for patients, healthcare providers and communities. ASP is based in Irvine, California with offices around the world. For more information, please visit www.aspjj.com or follow us at www.Twitter.com/aspjj.


Johnson & Johnson announced that it has received a binding offer from Fortive Corporation to acquire Advanced Sterilization Products(ASP). If the offer is accepted, the proposed transaction would be expected to close no later than early 2019, subject to customary closing conditions and regulatory approvals. Should you receive and accept an offer for this position, upon completion of the transaction, your employment with ASP will transfer to Fortive according to local law and will be governed by Fortive’s employment processes, programs, policies and benefits plans.


You, the Supervisor, Customer Quality will be responsible for maintaining the quality processes associated with product complaint handling, procedures, and controls to ensure that all complaints are processed in accordance with established company procedures and worldwide regulations and standards. You, will review documentation from incoming calls, faxes, and emails from all areas of the world. This individual will also obtain adequate information to ensure proper documentation, investigation, and closure of each complaint, in order to make and document sound regulatory reporting decisions/justifications for worldwide reporting. The individual applies standard practices and techniques in specific situations, adjusts and correlates data, recognizes discrepancies in results, and follows operations through a series of related detailed steps and processes.


You, the Supervisor, Customer Quality will:
  • Be responsible for the overall Complaint Management process (Entry, Closure, Follow ups, etc)
  • Develop and coordinate workload of Complaints Analysts
  • Be Responsible for CSS and J&J Complaints Metric
  • Plan, develops, coordinate and/or support Departmental projects from different levels of complexity
  • Be responsible for ensuring all required information for a complaint file is obtained and properly documented to make sound regulatory reporting decisions.
  • Set up complaint meetings and effectively communicate with worldwide complaint groups, as well as other internal departments such as Marketing, R&D, Customer Service and Technical Services.
  • Establish reports for the prompt review of new complaints, regulatory reporting decisions, and follow-up.
  • Guarantees all complaints are processed on a timely manner
  • Possess a thorough understanding of the complaint database.
  • Develop, establish, prepare and distribute dashboards and reports to assure complaints are processed in a timely manner.
  • Deeply understands principles, theories, concepts and techniques related to customer complaints.
  • Investigate and develop solutions to procedures and process related issues to next management level.
  • Escalate critical issues for proper disposition as necessary.
  • In a supervisory capacity, develops, mentors, plans and coordinates workload for Complaints Analysts.
  • In a supervisory capacity, plans, develops, coordinates, and directs projects with varying levels of complexity.
  • In a supervisory capacity, plans, develops, coordinates, mentors, and directs technicians and junior level engineers.
  • Responsible for conducting Performance Reviews and set Goals & Objectives for Complaints Analysts.
  • Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
  • Investigate and develop solutions to procedure and process related issues.
  • Responsible for conducting Performance Reviews and set Goals & Objectives for Complaints Analysts
  • Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, CMDCAS, PMDA and other worldwide regulatory agencies, Johnson & Johnson Environmental, Health & Safety Practices, and other applicable standards as pertains to medical devices.
  • Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
  • Performs other duties as needed.

Qualifications
  • A bachelor’s degree is required
  • A minimum of 6 years of related experience in regulated industry is required.
  • A Master’s degree is preferred.
  • American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools are preferred.
  • Supervisory and leadership skills are preferred.
  • Regulatory compliance knowledge is required.
  • Excellent interpersonal skills are required.
  • Advanced Quality Assurance and Quality Systems knowledge is required.
  • Problem solving and Statistical Skills are preferred.
  • The basic understanding of engineering fundamentals is preferred.
  • Critical thinking and investigation skills are required.
  • Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required.
  • Ability to understand and follow complex written procedures is required.
  • Familiarity with general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), and document change control practice is preferred.
  • Ability to function in a team environment and deliver on team objectives is required.
  • Project management and/or process mapping experience is preferred.
  • Strong written and verbal communication skills are required.
  • Experience with word processor software (e.g. Microsoft Word) and internet browsers (e.g. Internet Explorer) is required.
  • Experience with complaint management systems is preferred.
  • This position will be located in Irvine, CA and may require up to 10% domestic and/or international travel.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.



Primary Location
United States-California-Irvine
Organization
Biosense Webster Inc. (6010)
Job Function
Quality (Eng)
Requisition ID
7896180725