To develop update PFMEAs and document Quality plans and procedures as required. Prevent and resolve Quality problems. Improve areas of high-quality costs. Represent quality interests and concerns on project teams. Conduct root cause analysis and investigation for customer complaints and non-conformance product. Ensure compliance with Corporate, ISO, FDA, and Local standards requirements.
Job Responsabilities:
• Update PFMEAs.
• Provides direct technical guidance to QA supervisors or QA technicians
• Provide technical support to resolve quality problems in development, pilot, manufacturing
• Design and conduct quality engineering studies to determine causes of quality nonconformances,
initiate changes in process, tooling, etc., to correct them.
• Make dispositions of rejected nonconforming products’ conduct MRB action when required.
• Assure segregation and identification of rejected material and implementation of disposition by
production personnel.
• Organize and generate detailed quality information reports to engineering, manufacturing, and
management.
• Provide documented instructions for performance of QC inspections, including QC plans,
inspection and test procedures, and quality Standards.
• Plan and coordinate quality activities which involve production, engineering, etc.
• Exercise control over the quality of conformance of the products generated in his area\Design and
qualify inspection and test equipment.
• Mandatory compliance to general and safety procedures applying to this position.
• Additional activities assigned as required.
• Complete ERP transactions when required.
• The QA Engineer has the authority to develop and document plans in order to prevent and resolve
quality issues. Additionally, has the authority to put product on hold and release product as per
applicable procedures.
• Lead and guide peers and direct-reporting personnel, on how to conduct the Nonconformance
process (NC).
• Development of Test Methods.
• Development of Control Plans.
• Approve/support validations protocols (Software/IQs/OPs/PQs) if applicable.
Act as SME of Validations for process, AME and Test Methods.
Knowledge and Skills:
• Knowledge on International Regulations and Standards (i.e., ISO-13485, FDA, etc.).
• Certified as Quality Engineer (Preferable).
• Knowledge on basic Quality Tools and statistical techniques. (Control charts, sampling plans,
Design of experiments, etc.).
• Knowledge on Quality systems.
• Communication, Reports, Data analysis.
• Root cause analysis techniques.
• Able to work under pressure.
• Ability to communicate in English (Oral and written) fluently (preferably).
Education and Experience:
• Bachelor’s degree in technical sciences or Engineering.
• Minimum 3 years’ experience in Quality Assurance with background as QA Engineer and
Supervision.
• Medical Device Background (Preferable).
Required Skills
Optional Skills
.