Senior Quality Engineer

Supporting sustain quality activities & events for sterile and accessories products in production (in-house and outsourced)
Data collection , analyzing & presentations – periodic reports and trend analysis (MRB, complaints, Yields)
Cross Quality meetings lead, preparation and distribution of meeting summaries for sterile and accessories
Lead and determine quality requirements for production site & processes improvements.
Complaint trending analysis on quarterly basis.
Field complaint investigations& production quality investigations.
Establish pFMEAs and maintain on a quarterly basis.
Quality plans & report initiation, including FAI plans & reports for new parts & projects related to engineering changes. (cost reduction, production transfer etc.)
Define & initiate quality info records where applicable. Change order initiation for new make part manufacturers.
Determine critical indicators for critical to quality parts.
SCAR (supplier corrective action request) initiation and follow up.
Relevant QA SOP’s update.
Quality related trainings.

Requirements:

Quality education – CQM or CQE.
Quality or Statistic bachelor's/master’s degree or Electronic/Mechanical engineer.
At least 5 years of experience in a similar role in a medical devices company.
Ability of review determination of process validation plans protocols and approvals.
Knowledge of product Life Cycle method’s and control, medical standards /regulations and general standards knowledge (such as: ISO13485, FDA – QSR, MDD/R, IEC 60601, etc.’)
Multi-tasking and objective dedication.
Good interpersonal relationship.
Excellent English. (Must)