NDS Surgical Imaging

 

Print Job Description  CloseClose Window

Quality Management System Engineer

JOB SUMMARY:                                         
Quality Management System Engineer (QMSE) will play a key role in coordinating, improving, deploying and maintaining NDS Surgical Imaging quality management system globally.

 

ESSENTIAL FUNCTIONS:

  • Maintain and coordinate the deployment of NDS Quality System at the headquarters and remote offices.
  • NDS Quality System training: schedule and provide periodic Quality System training for new employees and re-training of the existing employees. Maintain employees training plans, training schedule and records.
  • Document Control: maintain Quality Manual, Quality System SOPs – Work Instructions - Forms, Customer Audit and Survey records, Supplier qualifications and management records, Training Records, External and Internal Audit Records, Design History File (DHF), Device Master Record (DMR), Device History Records (DHR).
  • External standards: track and maintain external governing regulations, standards.
  • Management Review: plan, coordinate objectives matrix collection and presentation.
  • Corrective and Preventive Actions: monitor and coordinate CAR, PAR, SCAR review meetings, create CAR, PAR, SCAR trending monthly reports; work with cross-functional team and/or suppliers in CAR investigation and root cause analysis; develop corrective actions for reported quality issues with effectiveness measurement.
  • Complaints and MDR evaluations: monitor and maintain Complaint and MDR evaluation records.
  • External audits: coordinate documents/records preparation to ensure timely response to documents requested from auditors and respond timely to audit findings.
  • Internal, Supplier audits: facilitate audits schedule, perform audits and identify improvement opportunities.
  • Statistical process control: analyze Quality System objectives data to evaluate effectiveness of company quality management system.
  • Nonconforming material (NCR): facilitate and monitor Material Review Board (MRB) activities.
  • Perform other essential duties as directed.

 

EDUCATION/EXPERIENCE:

  • Bachelor's Degree in Engineering (Biomedical, BioTech, Electrical, Computer or Industrial Engineering).
  • 3-5 years of experience in Medical Device Quality Management System required.
  • Quality System development, deployment, training, internal audit, document control, supplier management and development.
  • Working experience with medical device regulations (FDA 21 CFR 11, 820), international regulations and standards (MDD, ISO 9001:2008, 13485:2003, 14971:2007) required.
  • Experience in using ERP, Quality System Management.
  • Must have ISO certification for 9001:2008, 13485:2003, 14971:2007 Lead Auditor, CQA.

 

ADDITIONAL SKILLS AND KNOWLEDGE:

  • Strong written and presentation skills; ability to read and interpret applicable FDA regulations, ISO standards, Quality System documents.
  • Proficiency in MS Office 2007; Word, Excel, Publisher, Visio, etc.
  • Familiar with non-compliance trending statistic analysis methodology and tools.
  • Ability to work independently and in a team environment and manage multiple tasks effectively in a very fast paced work environment.
  • Ability to lift up to 60 lbs; and stand, walk, and sit for extended period of time.

 

For consideration, please send your resume to careers@ndssi.com