Engineer,Supplier Quality-TR

📁
Quality
📅
191CU Requisition #
JOB SUMMARY:
This position assures company compliance to all pertinent requirements which are applicable to the design, manufacture and distribution of medical and diagnostic devices by performing the following duties:

ESSENTIAL/PRIMARY DUTIES:
  • Develop and maintain supplier quality improvement program.
  • Investigates supplied-product quality issues and works directly with suppliers to ensure appropriate containment steps and corrective actions are taken in a timely manner. Works with suppliers to confirm corrective action plans are effective.
  • Prepares monthly performance reports for supplier quality improvement program.
  • Oversees the incoming inspection process to ensure continuous flow of quality materials to the manufacturing plant and alignment of inspection methods.
  • Responsible for identifying and resolving specification alignment issues between manufacturing (process) requirements and supplied product. Facilitate resolution of MRB issues.
  • Conducts and documents regular visits/audits to assigned suppliers to review manufacturing processes, quality systems / controls, pre-launch readiness, root cause identification, corrective actions, and process improvement opportunities.
  • Meet company and department goals in continuous improvement of all products, services, and processes.

SECONDARY DUTIES:
  • In Oracle transacts inventory for supplied, non-conforming parts
  • Predicts and communicates operational impacts due to non-conforming, supplied parts
  • Inputs supplied, non-conforming data into the Quality log 
  • Communicates non-conforming information to the supplier to obtain approval to return parts. 
  • Manages parts returned to suppliers for evaluation and/or rework   
  • Support supplier quality improvement initiatives 
  • Use MPS principles to improve business conditions
  • Prepares graphs or charts of data or enters data into computer for analysis.
  • Prepares and presents technical and program information to team members and management.
  • Maintains a working knowledge of government and industry quality codes and standards.
  • Communicates significant issues or developments identified during quality activities and provide recommended process improvements to management.
  • Recommends modifications of existing quality or production standards to achieve optimum quality within limits of equipment capability.
  • Performs in process audits to verify process control
  • Evaluates Device records 
  • Support calibration system including calibration frequency rationales and out of calibration reports
  • Review first article inspection submissions and maintain FAI reports and samples

EDUCATION and/or EXPERIENCE:
  • Bachelor's degree (B. A.) from four-year College or university; or one to 3 years related experience and/or training; or equivalent combination of education and experience.

COMPETENCY/SKILL REQUIREMENTS: 
  • Familiarity with ISO 13485 and 21 CFR 820 especially on Purchasing Controls
  • Process validation and test method qualification
  • Auditing to Quality Systems and Manufacturing processes
  • Root cause investigation

SUPERVISORY RESPONSIBILITIES: 
  • May supervise Quality Control Technicians and/or Returned Goods Technicians. There would typically be less than 5 direct reports if applicable.

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