Change Control Quality Engineer
Location:
Irvine , California
Posted:
December 24, 2016
Reference:
0613161114-en-us

The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Change Control Quality Engineer located in Irvine, CA.

 

The CSS Group consists of six diverse businesses including Acclarent, Advanced Sterilization Products (ASP), Biosense Webster (BWI), Codman Neuro, Mentor, and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Neurovascular and Neurosurgery, Surgical and Non-Surgical Aesthetics, and Reprocessing.

 

Advanced Sterilization Products (ASP), division of Ethicon, Inc., a Johnson & Johnson company, truly makes a difference by Protecting Lives against Infection. ASP has been innovating since 1987 to help healthcare facilities protect patients with best-in-class infection prevention solutions. Learn more about Advanced Sterilization Products at www.aspjj.com/us

 

 

The Change Control Quality Engineer is responsible for providing engineering support to the Change Process at ASP and facilitating change orders through the process by effectively guiding Change Order Owners to complete a thorough change and adequate documentation.


Responsibilities:

  • Provide support for CAPAs and Non-Conformances as needed.     
  • Facilitates Change Orders (CO) through process; ensures data integrity of each CO to assure clarity and completeness.
  • Verifies change classification; Analyzes and evaluates supporting documentation to ensure that each change is effective.              
  • Generate monthly CO metrics.                                                       
  • Schedule weekly Change Control Board meetings and prepares the agenda.  
  • Facilitate weekly CCB meetings and confirm team consensus, resolve outstanding issues.                                                           
  • Support internal and external audits as needed.    
  • Processes change orders (COs), document requests, and assign document numbers as requested.                  
  • Reviews Quality System documentation.
  • Creates and revises documentation to improve change control document systems and revises procedures as needed.                       
  • Provide guidance and support to other functional areas with documentation needs and issues.                        
  • Provides CO training and supports records management as needed.   
  • Exercises independent discretion and judgment, and solves intermediate complex problems.
  • Some latitude to change work processes and workflow is provided.
  • Performs administrative duties requiring limited autonomy in making decisions independent of the current supervisor or that of the department. 
  • Knowledge of all departmental objectives and working knowledge of company operations and organization is required.
  • Department organizational structure knowledge is required


Qualifications

Qualifications:

  • Bachelor Degree is required. Bachelor’s Degree in Engineering Science or related technical field is highly preferred.
  • 2-3 years in Pharmaceutical and/or Medical Device Company is required.
  • Knowledge of GDP, QSR, and ISO standards required.      
  • Good attention to detail, organizational skills and interpersonal and communication skills are required.                                       
  • Excellent time management and problem solving skills are required.
  • Proficient in Microsoft Office applications, Adobe Acrobat, and some knowledge of database application are required. 
  • Knowledge of document and data control software systems required.   
  • Knowledge of FDA and ISO13485 requirements are required.        
  • Knowledge/understanding of rules of part number interchangeability, effectivity statements, configuration management, multi-database BOM structure and interactions, and product processes as they relate to manufacturing sites, system hierarchy and control/traceability requirements.  
  • Prior exposure to various functions of corporate organization is desired.     
  • A Configuration Management Certification is preferred.          
  • Must demonstrate solid documentation experience of document change control process.        
  • Good written communication skills to be able to articulate clear and concise policies and easily understood procedures.     
  • Previous experience with configuration management of product data and process instruction is preferred.
  • Experience in working in change control and/or configuration management systems is preferred.                      
  • Experience in working with product development and/or manufacturing is preferred.      
  • Experience working with global suppliers and partners is preferred.
  • This position is located in Irvine, CA. and may 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.


Johnson & Johnson Companies are equal opportunity employers.



Primary Location
United States-California-Irvine
Organization
Advanced Sterilization Products (ASP)
Job Function
Quality Systems

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

Know someone who would be interested in this job? Share it with your network.