Senior Manager, CSS Customer Quality
Location:
Irvine , California
Posted:
March 08, 2017
Reference:
000014DO/1-en-us

 The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting a Senior Manager, CSS Customer Quality, to be located at one of our network locations (Irvine, CA; Irwindale, CA; Irving, TX; Juarez, Mexico).
 
The CSS Group consists of six diverse businesses including Advanced Sterilization Products (ASP), Acclarent, Biosense Webster, Mentor, SEDASYS® and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology, Surgical and Non-Surgical Aesthetics, Sedation and Reprocessing. The CSS Group is committed to delivering innovative products, solutions and programs to address unmet customer and patient needs around the world. Our customers and the patients they treat are our first priority and these values are reflected in Our Credo, which guides our daily decisions and actions. Our relentless commitment to Quality and the principles that define us in Our Credo have helped us achieve significant milestones and continues to help us deliver significant growth year after year.
 
Position Overview:
The Senior Manager, CSS Customer Quality will be responsible for the management and leadership of an international Customer Quality Organization to include the JNJ Operating companies referenced above.
 
General Responsibilities:
  • The Senior Manager will have overall responsibility for day-to-day complaint processing at multiple company locations, including Irvine CA, Irwindale CA, Irving TX, and Juarez Mexico.  Responsibility includes ensuring customer complaint investigation processes are compliant, effective, and efficient.
  • Leading a team of individuals through completion of reportability determinations, investigation and closure of reportable and non-reportable product complaints in accordance with established company procedures and worldwide regulations and standards.  May supervisor other people leaders.
  • The role requires approval of complaint investigations and MedWatch Reports (MDR), escalating trends and product problems, and remaining abreast of new or revised regulations and/or guidelines. 
  • The Senior Manager will drive continuous improvement through corrective and preventive action processes, leading continuous improvement activities, and providing subject matter expertise on complaint handling requirements.
  • Reviews and continuously leads efforts to improve the global complaint handling process. 
  • Maintains and continuously improves highly effective procedures for complaint processing and complaint investigation.  Drives harmonization across the network.
  • Collaborates with the Field Service Engineering, Medical Safety, Medical Affairs, Manufacturing, international and other departments to ensure complaint investigations are complete, thorough, timely and meet regulatory reporting requirements.
  • Maintains dashboards and other reports of performance metrics.
  • Measures key performance indicators to assess the health of the complaint investigation process. 
  • Provides regular updates and status reports to Senior Management. Initiates company issue escalation process as required.
  • Initiates company CAPA process as required. Response for CAPA investigations and implementation of action plans.
  • Authors and approves customer response letters. Reviews and approves investigations completed by associates, including investigations related to reportable complaints.
  • Coordinates efforts with J&J Legal Department for complaints regarding litigation.
  • Independently completes reportability determination for US Medical Device Reports and reports required in other regions.
  • Completes Medical Device Reports and international equivalents to comply with government reporting requirements.
  • Approves regulatory reports for submission to US FDA and other regulators.
  • Drafts response communications to inquiries from regulators.
  • Remains informed of new or revised regulations and/or guidelines, and assesses impact on company complaint handling processes.
  • Supports internal and external audits (e.g. FDA) of complaint handling department. 
  • Serve as a subject matter expert (SME) for complaint processing, complaint investigation and MDR reporting during audits and inspections.
  • Maintains compliance to applicable foreign and domestic regulations governing the management and processing of medical device related complaints including Protected Health Information (PHI) and patient privacy laws.
  • The position will collaborate closely with other CSS departments to maintain compliance within the Customer Quality process.
 
People Leadership Responsibilities:
  • Provides management direction, motivation, and support for department personnel.  May supervisor other people leaders.
  • Provides leadership to complaint handling staff to ensure complaint files are processed in a uniform and timely manner. 
  • May be responsible for management of employees or contractors at remote work sites.
  • Ensures that each staff member has clearly established goals and objectives, monitors staff performance, conducts periodic performance evaluations and compensation planning, and ensures succession planning for key positions, including own.
  • Develops, coordinates, and otherwise ensures appropriate training for associates. 
  • Ensures individualized developmental plans are in place for all associates.

Qualifications
Requirements:

The following skills, abilities and certifications are either required or preferred as noted:

  • A Bachelor’s degree in Science, Engineering, Nursing, Biology, Chemistry or related technical field is required. 
  • 8+ years of related experience, including significant experience working in pharmaceutical, consumer, medical device or another highly regulated industry.
  • 6+ years of experience managing people and managing projects is required.  
  • Proven leadership in developing and coaching staff is required.
  • Advanced 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. 
  • Employee must be able to effectively prioritize and manage multiple activities and responsibilities.
  • Ability to understand and follow complex written procedures is required. 
  • Candidates should be familiar with general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), and document change control practices.
  • Ability to function in a team environment and deliver on team objectives is required. 
  • Ability to influence and drive change is preferred. 
  • Project management and/or process mapping experience.
  • Strong written and verbal communication skills are required.
  • Developed presentation skills.
  • Professional demeanor on the phone and in email is required. 
  • Strong attention to detail is required.
  • Ability to learn and manipulate complex computer system applications is required.  Prefer experience with electronic Complaint Management Systems.
  • Require prior medical device complaint handling experience, or knowledge of medical device regulations.
  • This position is located at a company site and may require up to 20% travel.
 
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Primary Location
United States-California-Irvine
Other Locations
North America-United States-California-Irwindale, North America-United States-Texas-Irving, Latin America-Mexico-Chihuahua-Juarez
Organization
Biosense Webster Inc. (6010)
Job Function
Quality Assurance

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