Quality Engineer I

ID# DCCA29840

dinaliC is an international consulting firm specialized in projects for numerous industries. We are dedicated to provide contract and permanent opportunities for skilled professionals in their area or areas of expertise

  • JOB OVERVIEW 

PURPOSE: 

  • Performs investigations relating to root cause of customer complaints, proposes and implements corrective and preventative actions as required. 

EDUCATION 

  • BS in an engineering or related technical field, Mechanical, Electrical, Materials, Math, Statistics etc 
  • 1-5 years experience with BS 
  • 0-3 years experience with MS 

EXPERIENCE REQUIRED: 

  • Ability to apply technical, regulatory, quality systems, and business knowledge to identify, investigate and resolve customer complaints. 
  • Demonstrated ability to work effectively with cross-functional teams for complaint investigation, root cause analysis, identification and implementation of CAPAs. 
  • Ability to effectively prioritize and manage multiple activities and responsibilities. 
  • Excellent written and verbal technical and business communication skills. 
  • Technical skills in areas of business applications like excel or other related database systems. 
  • Solve multidisciplinary engineering problems at the component through system level. 
  • Conduct testing utilizing existing test protocols or develop new ones as needed. 
  • Generate well written reports. 

Preferred: 

  • Experience in a Quality functional area with competency in Quality System Regulations. 
  • Experience with the application of systemic and investigative tools (Pex, Six Sigma, SPC, Pareto Charting) to evaluate product quality attributes and failure modes. 
  • Broad based technical knowledge and skills in diverse areas of business a plus (Operations, R&D, Field Service). 

KEY JOB RESPONSIBILITIES: 

  • Responsible for investigating customer complaints for product quality issues and concerns, including the preparation of written failure investigations. Researches device history records associated with the manufacture of the product. 
  • Works on complex investigations and coordinates technical teams to ensure sound experimental design, effective data analysis, identification, implementation, verification and validation of CAPA, and subsequent closure of investigations. 
  • Prepares and performs analysis of customer complaint data and identifies potential product quality trends. 
  • Leads effort to identify corrective and preventative actions based on root cause failure investigations. 
  • Assesses customer complaints for potential regulatory reporting, based on product specific criteria. 
  • Drives quality based, data driven decisions, with appropriate approval authority 
  • Erroneous decisions or recommendations or failure to achieve results might cause delays in implementing CAPA and increase the quantity of complaints resulting in customer dissatisfaction. 

ENVIRONMENTAL, HEALTH AND SAFETY: 

All employees have a duty to care for their safety and for the safety of others whom may be affected by their acts or omissions at work and the environment. Therefore it is the duty of every employee to: 

  • Respect and apply safety rules and procedures at all times 
  • Use personal protective equipment and safety devices as required 
  • Promote industrial hygiene and safety matters 
  • Report incidents and damages to management whether injuries are involved or not 
  • Participate in incident investigation 
  • Report hazards to management 
  • Ensure a high standard of housekeeping in the work area 
  • Be a safety role-model to all employees 
  • Make suggestions to improve safety at the workplace 
  • Actively participate in department EHS committee Engage in environmental awareness and participation towards environmental goals and programs 

COMPLIANCE: 

All employees have a duty to comply with applicable laws, regulations, standards, company‚Äôs policies and procedures. 

Examples of required areas of compliance include but are not limited to: 

  • Quality Systems (including Product Complaints, Corrective and Preventive Actions (CAPA), Internal Audits, Good Manufacturing Procedures (GMP), and Good Documentation Practices (GDP)) 
  • Sarbanes-Oxley (SOX) 
  • Health Care Compliance (HCC) 
  • Government Contract Compliance (GCC) 
  • Environmental Regulations 
  • Records Management 


 

Position Details:

Medical Device

Engineering

Start Date: 
2-24-2014
End Date: 
1-17-2015

IRVINE, CA

CON_W2

40

DCCA29840

No

No